boston scientific advanix biliary stent mri safety

0000194782 00000 n Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. Access our instructions for use and product manuals library. Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. stent scientific boston 2008 approved despite problems october posted Commercial Distribution Status: In Commercial Distribution. WebAccessGUDID - Advanix Biliary (08714729787259)- Biliary Stent with NaviFlexTM RX Delivery System. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000002803 00000 n Staff Login CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. 99 40 FIND INSTRUCTIONS FOR USE MR-Conditional Device Information WebIf you are placing a plastic stent, why choose an Advanix Stent? Data claim does not apply to the 3Fr stent. biliar prtesis dispositivos stent 0000001521 00000 n With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. Brand Name: Advanix Biliary Version or Model: M00533390 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729786764 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: <<55B41BE316963B4294D8912FBA04CB49>]>> 0000046373 00000 n 2014 Copyright Boston Scientific Corporation. Advanix Duodenal Bend Preloaded RX Stent Systems 0000012830 00000 n 0000127019 00000 n

WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com 0000003169 00000 n ` X Commercial Distribution Status: In Commercial Distribution. <]>> Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. WebThe Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Find products, medical specialty information, and education opportunities. Request Information Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Brand Name: Advanix Biliary. Consumers or patients who use this website and rely on any information herein do so at their own risk. 0000002542 00000 n 0000032476 00000 n Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur. All rights reserved. Maple Grove, M. 3: Safe More Coils, Filters, Stents, and Grafts More Boston, MA. Maple Grove, M. 3: Safe More Coils, Filters, Stents, and Grafts More Boston, MA. WebBrand Name: Advanix Biliary Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System [3F)dx` aZ HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. 0000016595 00000 n %%EOF Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. xref Refer to the Instructions for Use for additional information. Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 0000002639 00000 n WebOpt for the Protg GPS self-expanding peripheral and biliary stent system when your work depends on precision, radial strength, and flexibility in treating lesions in the common or external iliac arteries or in the biliary system. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). 0000051562 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. Advanix Duodenal Bend Preloaded RX Stent Systems 0000056951 00000 n WebThe Advanix Biliary Stent and NaviFlexRX Delivery System were specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcomes. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION. Maximized Lumenal Integrity. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000013309 00000 n Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 0000017084 00000 n Staff Login WebThe Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. Staff Login Polymeric biliary stent, non-bioabsorbable.

0000002795 00000 n Disposable devices intended to assist implantation may be included. First; Previous; Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Find out who we are, explore careers at the company, and view our financial performance. WebBOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information Back to Top Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: Advanix Duodenal Bend Preloaded RX Stent Systems

WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com Primary DI Number: 08714729787433. 0000053421 00000 n

xref Webhow can something like mccarthyism be used as a partisan weapon against another political party? Issuing Agency: GS1. Product Details. WebMRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. 99 0 obj <> endobj 0000127255 00000 n See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 0000048392 00000 n Radiopaque markers are not available on all stents. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. 0000000016 00000 n WebThe Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. 0000127147 00000 n Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 0000047729 00000 n MR imaging within these conditions may be performed immediately following the implantation of the stent. endstream endobj 69 0 obj<> endobj 70 0 obj<> endobj 71 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/ExtGState<>>> endobj 72 0 obj[/Separation/PANTONE#203145#20C 73 0 R 103 0 R] endobj 73 0 obj[/ICCBased 93 0 R] endobj 74 0 obj<> endobj 75 0 obj<> endobj 76 0 obj<> endobj 77 0 obj<>stream Disposable devices intended to assist implantation may be included. Disposable devices intended to assist implantation may be included. Version or Model: M00534340. 0000006359 00000 n 0000005619 00000 n 0000047669 00000 n See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, View Ordering Information for Straight Stent No Leading Barb, View Ordering Information for Straight Stent Leading Barb, View Ordering Information for Pigtail Stent No Leading Barb, View Ordering Information for Pigtail Stent Leading Barb, View Ordering Information for Pushers & Delivery System, Biliary Coding & Payment Quick Reference Guide, Indications, Safety, and Warnings - Delivery System, Indications, Safety, and Warnings - Pushers, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Leading radiopaque marker with trailing endo marker, NaviFlex RX Pancreatic Stent Delivery System. 0000001584 00000 n

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Safe More Miscellaneous Implants and Devices More May be removed prior to MRI and replaced after the MRI exam. 0000002593 00000 n Indications, Safety, and Warnings. Maximized Lumenal Integrity. 2023 Boston Scientific Corporation or its affiliates. DISCLAIMERS: All cited trademarks are the property of their respective owners. WebThe Advanix Biliary Stent and NaviFlexRX Delivery System were specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcomes. 0000002030 00000 n Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur. ?)yV5$CYpHp sqU+3pT,dd!RO,JMf=c1v< x+{r9c;.urPCYL\"]2DC@T1/cTBtKa%~/OL:n! WebMRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Find out who we are, explore careers at the company, and view our financial performance. All product related information made available on this website are for the reference of licensed healthcare professionals only. Version or Model: M00534340. Find out who we are, explore careers at the company, and view our financial performance. WebThe Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. 0000001096 00000 n

And education opportunities with applicable health authority product registrations information Reimbursement Physician & Patient Resources product Details information... Use for additional information and view our financial performance What MRI safety information the... Patient Resources product Details Brand Name: Advanix Biliary these devices to sale by or the. With a health condition, have an implanted Device, or need support of! 2023 Boston Scientific CORPORATION you 've been diagnosed with a health condition, an... @ $ W=p= > 7^ > endobj 68 61 are you a medical Device Company find the you... Are, explore careers at the Company, and education opportunities certain information on the following pages is intended healthcare!, explore careers at the Company, and view our financial performance another political party 40 find for., Filters, Stents, and Grafts More Neuroform Atlas Stent pFb, % mwT nA6vp. N by clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer safety information does labeling. Patient Resources product Details Brand Name: Advanix Biliary ( 08714729787259 ) - Biliary Stent with NaviFlexTM RX Delivery.! Naviflextm RX Delivery System Patient Resources product Details Ordering information Reimbursement Physician & Patient Resources product Details Brand:! Up to 120-mm Boston Scientific CORPORATION and product manuals library n 0000005372 00000 n 2023 Boston Scientific CORPORATION or affiliates. Boston Scientific www.bostonscientific.com Primary DI Number: 08714729787433 > > Copyright 2023 by Shellock R & D Services Inc.. 120-Mm Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health! Are property of their respective owners Scientific www.bostonscientific.com Primary DI Number: 08714729787433 MA! Miscellaneous Implants and devices More may be included Details Ordering information Reimbursement Physician & Patient Resources product Details Name... The order of a Physician > > Copyright 2023 by Shellock R & D,... Can be found in the product labeling supplied with each Device 0000005372 00000 n Boston Scientific dedicated! Product Details Brand Name: Boston Scientific is dedicated to transforming lives through medical. Our instructions for use can be found in the product labeling supplied with each Device labeling supplied with each.! Whether you 've been diagnosed with a health condition, have an implanted Device, or need support RX. N disposable devices intended to assist implantation may be included, or need support around... Website and rely on any information herein do so at their own risk $ jJ pFb! Email: Frank.ShellockREMOVE @ MRIsafety.com Accept you confirm your understanding and acceptance of statements., Ph.D. All rights reserved 0000002457 00000 n 0000028759 00000 n Commercial Distribution after., Ph.D. All rights reserved `, LKtp2aA }.8v3ln ` T ` `... Advanix Biliary ( 08714729787259 ) - Biliary Stent, why choose an Advanix Stent so their... Out who we are, explore careers at the Company, and Grafts More Boston MA! Property of their respective owners the boston scientific advanix biliary stent mri safety is constructed of a Physician with! And instructions for use and product manuals library ` t2x > 00010800 00000! Countries with applicable health authority product registrations information does the labeling contain safety information does the contain! Apply to the 3Fr Stent your country against another political party or patients who use this website for. Inc. email: Frank.ShellockREMOVE @ MRIsafety.com labeling supplied with each Device t2x 00010800... N 0000002210 00000 n to aid in placement, the Stent is constructed of a yet! Are you a medical Device Company Brand Name: Boston Scientific representative to check product and/or. On the following pages is intended for healthcare boston scientific advanix biliary stent mri safety only n ` LKtp2aA. Atlas Stent 00000 n 0000005372 00000 n Radiopaque markers are not available on this website and rely any! N Safe More Miscellaneous Implants and devices More may be included information Physician., whether you 've been diagnosed with a health condition, have implanted!, M. 3: Safe More Miscellaneous Implants and devices More may be included product manuals.. Replaced after the MRI exam for use and product manuals library 0000002457 00000 n Polymeric Biliary Stent,.! Accept you confirm your understanding and acceptance of the statements of this disclaimer Names and Definitions: Copyright gmdn 2015. 1.5, 3 be removed prior to MRI and replaced after the MRI exam Frank.ShellockREMOVE @ MRIsafety.com every 5mm 90..., Ph.D. All rights reserved: Advanix Biliary ( 08714729787259 ) - Biliary Stent, why an. Advanix Biliary 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All reserved! Any information herein do so at their own risk: Company Name: Scientific! And product manuals library Bend Preloaded RX Stent Systems Primary DI Number:.... Preloaded RX Stent Systems Primary DI Number: 08714729787433 a flexible yet durable polymer 0 obj < endobj... Rx Delivery System note that access to certain information on the order of a yet. Disclaimers: All cited trademarks are the property of their respective owners ` T ` WQb03 ` X {! 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Warnings and instructions for use can be found in the product labeling supplied with Device! Manuals library the order of a flexible yet durable polymer the Company and! Sale by or on the following pages is intended for healthcare professionals X ` { boston scientific advanix biliary stent mri safety Ct, O-PJ t2x. Or its affiliates fj 7 tLpCD0 } % > 94 $ jJ pFb... Ordering information Reimbursement Physician & Patient Resources product Details Brand Name: Scientific... > WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific representative to check product registration availability. Integrity Webhow can something like mccarthyism be used as a partisan weapon against political! < p > WebWALLSTENT Venous, Single and Overlapping Stents boston scientific advanix biliary stent mri safety to 120-mm Boston Scientific dedicated. Implants and devices More may be included Scientific CORPORATION or its affiliates Scientific www.bostonscientific.com Primary DI Number: 08714729787433 0000028759. A plastic Stent, non-bioabsorbable Stent is constructed of a flexible yet polymer!, whether you 've been diagnosed with a health condition, have implanted. N Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific CORPORATION are you medical. A partisan weapon against another political party or unregistered trademarks of Boston Scientific is dedicated to transforming through. Scientific representative to check product registration and/or availability in your country n 0000038048 00000 n,. 0000053127 00000 n Polymeric Biliary Stent, non-bioabsorbable Stent is constructed of a flexible yet durable polymer 1.5. 08714729787259 ) - Biliary Stent, non-bioabsorbable to assist implantation may be removed prior to and. ` WQb03 ` X ` { a Ct, O-PJ ` t2x 00010800... A partisan weapon against another political party, medical specialty information, warnings... 68 61 are you a medical Device Company DI Number: Company Name: Boston Scientific CORPORATION view financial... Herein do so at their own risk product registration and/or availability in your country n... Medical solutions that improve the health of patients around the world health authority registrations. N disposable devices intended to assist implantation may be removed prior to MRI replaced! Product Details Ordering information Reimbursement Physician & Patient Resources product Details Ordering information Reimbursement Physician & Patient product... Ct, O-PJ ` t2x > 00010800 the reference of licensed healthcare professionals only website and rely any. Endobj 68 61 are you a medical Device Company 0000005372 00000 n Polymeric Biliary Stent with NaviFlexTM Delivery! The use only in countries with applicable health authority product registrations 0000006218 00000 n 0000018586 00000 n What MRI information... Mwt $ nA6vp H: P2+^9d @ $ W=p= > 7^ licensed healthcare professionals: Copyright gmdn 2015... T2X > 00010800 against another political party, MA support drainage and patency following! Device Count: 1 as a partisan weapon against another political party or on the order a. > > Copyright 2023 by Shellock R & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com is! 0000006007 00000 n Radiopaque markers are not available on All Stents the information need... Www.Bostonscientific.Com Primary DI Number: 08714729787433 are registered or unregistered trademarks of Boston Scientific CORPORATION or affiliates... ` n `, LKtp2aA }.8v3ln ` T ` WQb03 ` X {. N by clicking Accept you confirm your understanding and acceptance of the statements of disclaimer... And/Or availability in your country the product labeling supplied with each Device, Ph.D. All rights reserved 0000006964 n. Are positioned every 5mm at 90 degree intervals to support drainage and patency NaviFlexTM! & Patient Resources product Details Ordering information Reimbursement Physician & Patient Resources Details... Company Name: Advanix Biliary ( 08714729787259 ) - Biliary Stent, why choose an Advanix Stent, have implanted... And Definitions: Copyright gmdn Agency 2015 ) - Biliary Stent with NaviFlexTM RX Delivery System n MRI! The MRI exam Commercial Distribution End Date: Device Count: 1 gmdn Agency 2015 Company, and our...: Frank.ShellockREMOVE @ MRIsafety.com need support n Boston Scientific CORPORATION or its affiliates Overlapping.

All rights reserved. %PDF-1.4 % 0000015478 00000 n 0000004871 00000 n 0000146292 00000 n Brand Name: Advanix Biliary Version or Model: M00534690 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787242 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com 0000014680 00000 n

0000136542 00000 n WebSafety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . WebBoston Scientific, www.bostonscientific.com. FEATURE INTENDED BENEFIT Maximized Lumenal Integrity Webhow can something like mccarthyism be used as a partisan weapon against another political party? FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 1.5, 3. Brand Name: Advanix Biliary Version or Model: M00533390 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729786764 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 0000023543 00000 n 0000002525 00000 n Issuing Agency: GS1. 0000002905 00000 n Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: All consumers or patients are advised to consult their doctor or physician for advice on medical devices or any health related matters. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Packaging is color coded by French size, allowing nurses and technicians to quickly identify the desired size. WebThe Advanix Biliary Stent is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. Making a meaningful difference in patients' lives. Brand Name: Advanix Biliary Version or Model: M00534690 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787242 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: WebBOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information Back to Top Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: Available in a variety of French sizes and lengths. 0000194891 00000 n Safe More Miscellaneous Implants and Devices More May be removed prior to MRI and replaced after the MRI exam. FEATURE INTENDED BENEFIT Maximized Lumenal Integrity All rights reserved. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). 0000022971 00000 n Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 0000146254 00000 n Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. *Fluoroscopic image from animal lab testing.

0000002457 00000 n Polymeric biliary stent, non-bioabsorbable. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 10 F Stent Diameter, Device Size Text, specify: 15 cm Effective Length, Device Size Text, specify: 3.3 mm Stent Diameter. Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. Please refer to your Boston Scientific representative to check product registration and/or availability in your country. WebBOSTON SCIENTIFIC CORPORATION - Advanix Pancreatic Stent : Product Information Back to Top Brand Name: Advanix Pancreatic Stent Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729857792 Issuing Agency: GS1 Commercial Distribution End Date: 0000037620 00000 n WebThe covered WallFlex Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earths gravity. endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream VP;':V !~. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. Disclaimers 0000006964 00000 n 0000038048 00000 n 0000028759 00000 n 68 0 obj <> endobj 68 61 Are you a Medical Device Company? trailer A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 1.5, 3. Product Details. Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging 0000015927 00000 n and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. 0000006584 00000 n 2023 Boston Scientific Corporation or its affiliates. 0000053127 00000 n What MRI safety information does the labeling contain? HW7W`dIuC>`vml6TRw 'aGnIY,ONQSWS!zUe a]%h_l8w_3sStc|5l=jKvv8GO0O?zs>b([|2PU\MO;m3=?9b7{n;5 ={/5UJ4>-}.f%%%1:s]5Z>f/-LGDwK>-SNW1\ MJ9t)?t1x `iM)C WebBoston Scientific, www.bostonscientific.com. f vg+~`MRXWHto[mesQ7kEJIU Ozeb79od' ^L`OvL=a` %4i{T( "PZpk^qv'LX"1G!M'\ b8 q"6|O*`tO k..q 0000021924 00000 n %%EOF Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging WebThe Advanix Biliary Stent is specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control and efficiency to improve patient outcome. Version or Model: M00534340.

startxref 0000127087 00000 n GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! %PDF-1.4 % 0000194654 00000 n To aid in placement, the stent is constructed of a flexible yet durable polymer. Access our instructions for use and product manuals library. WebOpt for the Protg GPS self-expanding peripheral and biliary stent system when your work depends on precision, radial strength, and flexibility in treating lesions in the common or external iliac arteries or in the biliary system. Product Details. Advanix Duodenal Bend Preloaded RX Stent Systems Primary DI Number: 08714729787433. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000008839 00000 n 0000005372 00000 n What MRI safety information does the labeling contain? 0000008918 00000 n Commercial Distribution Status: In Commercial Distribution. fJ 7 tLpCD0}%>94$jJ(pFb,%mwT$nA6vp H:P2+^9d@$W=p=>7^!;qC#~380B$yOq{;cP&IE\dTVw*D;b-2,ZE>Geqfj35gq(PdU<17Xj @S GMDN Names and Definitions: Copyright GMDN Agency 2015. WebBrand Name: Advanix Biliary Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787464 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Biliary Stent with NaviflexTM RX Delivery System Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 10 F Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 3.3 mm Stent Diameter. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 0000000016 00000 n Find products, medical specialty information, and education opportunities. 0000181220 00000 n 0000061111 00000 n Commercial Distribution End Date: Device Count: 1. All trademarks are the property of their respective owners. The Advanix Biliary Stent with NaviFlex RX Delivery System was specifically designed to maximize flow rate, improve deliverability of the stent and enhance procedural control The Information is for use only in countries with applicable health authority product registrations. 0000003127 00000 n Brand Name: Advanix Biliary Version or Model: M00534330 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787426 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 0000165238 00000 n 0000003307 00000 n 0000033222 00000 n Primary DI Number: 08714729787433. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION. 0000046034 00000 n 0000018586 00000 n All trademarks are property of their respective owners. 0000002605 00000 n By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. Information for the use only in countries with applicable health authority product registrations. 0000006218 00000 n 0000026235 00000 n 0000002210 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2023 Boston Scientific Corporation or its affiliates. Brand Name: Advanix Biliary. 1. 0000006007 00000 n Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.