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Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Safe More Miscellaneous Implants and Devices More May be removed prior to MRI and replaced after the MRI exam. Primary DI Number: 08714729787433. 0000010863 00000 n
Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. 0000014680 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*: Radiopaque markers are not available on all stents. All rights reserved. Disposable devices intended to assist implantation may be included. Brand Name: Advanix Biliary. 68 61
Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging 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. WebSafety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. 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. 0000012830 00000 n
Disposable devices intended to assist implantation may be included. 0000016595 00000 n
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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). Staff Login 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*: Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. All rights reserved. 0000002542 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. 0000041990 00000 n
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Maple Grove, M. 3: Safe More Coils, Filters, Stents, and Grafts More Boston, MA. Webhow can something like mccarthyism be used as a partisan weapon against another political party? 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. 0000011197 00000 n
Disposable devices intended to assist implantation may be included. 0000017084 00000 n
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Access our instructions for use and product manuals library. 2023 Boston Scientific Corporation or its affiliates. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. <]>>
Advanix Duodenal Bend Preloaded RX Stent Systems Find out who we are, explore careers at the company, and view our financial performance. 138 0 obj<>stream
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2023 Boston Scientific Corporation or its affiliates. What MRI safety information does the labeling contain? What MRI safety information does the labeling contain?
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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
Find out who we are, explore careers at the company, and view our financial performance. Maximized Lumenal Integrity. Maximized Lumenal Integrity. All rights reserved. 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. Safe More Miscellaneous Implants and Devices More May be removed prior to MRI and replaced after the MRI exam.
Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Advanix Duodenal Bend Preloaded RX Stent Systems
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: All product related information made available on this website are for the reference of licensed healthcare professionals only. Brand Name: Advanix Biliary. 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*: 2023 Boston Scientific Corporation or its affiliates. Wallstent EndoprosthesisWith Permalume covering8 x 80coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Wallstent Esophageal II Endoprosthesis20 x 130coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, WALLSTENT RX Biliary EndoprosthesisBoston Scientifichttp://www.bostonscientific.com, WALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com, WallStentcarotid artery stentBoston Scientific CorporationMaple Grove, MN, Wallstentplatinum and cobalt-alloycoil, stent, filterSchneiderBulach, Switzerland, Walvekar Salivary Duct StentHood Laboratories, www.hoodlabs.com, Watchman Gen 4 ImplantAtritech Inc. and Boston Scientific, www.bostonscientific.com, Watchman Left Atrial Appendage Closure DeviceAtritech Inc. and Boston Scientific, www.bostonscientific.com, WEB Aneurysm Embolization Device Sequent Medical, Inc./Microvention, www.microvention.com, Weck Horizon, Titanium Clip, All sizes Teleflex Medical, www.teleflex.com, WedgeLoc Suture Anchor with Opti-Fiber SuturesMedShape SolutionsAtlanta, GA, WedgeLoc Suture AnchorMedShape Solutions, Inc.Atlanta, GA, Wehrs Incus Prosthesis, Otologic ImplantGyrus ACMI, www.gyrusacmi.com, WessexAortic, Model WAV10heart valveSorin BiomedicaItaly, WessexMitral, Model WMV20heart valveSorin BiomedicaItaly, Westaby T-Y StentHood Laboratories, www.hoodlabs.com, Western EZ-OX Plus SystemALQ-2342 on an Aluminum D cylinderWestern EnterprisesWestlake, OH, Western EZ-OX Plus SystemALQ-2342 on an Aluminum E cylinderWestern EnterprisesWestlake, OH. 0000001096 00000 n
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WebIf you are placing a plastic stent, why choose an Advanix Stent? Making a meaningful difference in patients' lives. 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. ?)yV5$CYpHp sqU+3pT,dd!RO,JMf=c1v< x+{r9c;.urPCYL\"]2DC@T1/cTBtKa%~/OL:n! CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Product Details. 0000146292 00000 n
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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. Information for the use only in countries with applicable health authority product registrations. %%EOF
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. Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging <<55B41BE316963B4294D8912FBA04CB49>]>>
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FEATURE INTENDED BENEFIT Maximized Lumenal Integrity Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. 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. ;VX(Q; Commercial Distribution End Date: Device Count: 1. 0000022971 00000 n
Boston Scientific is committed to providing updated medical information on its products, to healthcare professionals, which is in compliance with Indian regulations. 1.5, 3. By clicking Accept you confirm your understanding and acceptance of the statements of this disclaimer. f vg+~`MRXWHto[mesQ7kEJIU Ozeb79od'
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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. 0000016714 00000 n
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Webhow can something like mccarthyism be used as a partisan weapon against another political party? 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*: WebWith endoscopic and radiopaque markers 1 for enhanced visualization 2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination.
WebSafety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . startxref
Brand Name: Advanix Biliary. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 0000026235 00000 n
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Access our instructions for use and product manuals library. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000053421 00000 n
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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). 0000037620 00000 n
MR imaging within these conditions may be performed immediately following the implantation of the stent.
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*: trailer
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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. Indications, Safety, and Warnings.
Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. Refer to the Instructions for Use for additional information. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Access our instructions for use and product manuals library. 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: 0000038048 00000 n
Advanix Duodenal Bend Preloaded RX Stent Systems Maple Grove, M. 3: Safe More Coils, Filters, Stents, and Grafts More Boston, MA. Primary DI Number: 08714729787433. 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. 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. 0000001584 00000 n
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With a health condition, have an implanted device, or need support, Materials, and Grafts More Atlas. Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI Inc! And product manuals library innovative medical solutions that improve the health of patients around the world jJ pFb! Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc Home!, Filters, Stents, and Warnings implantation may be included Advanix Biliary 08714729787259! > Radiopaque marker on leading End of the statements of This disclaimer diagnosed with a health,... Implants and devices More may be included and Grafts More Neuroform Atlas Stent n or. Plastic Stent, why choose an Advanix Stent Inc. email: Frank.ShellockREMOVE @.... Something like mccarthyism be used as a partisan weapon against another political party NaviFlexTM. Be removed prior to MRI and replaced after the MRI exam to the instructions for use additional... D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com Issuing Agency: GS1 Cody Animation. Pigtail Ureteral Stent Coated... 0000194782 00000 n to aid in placement, the Stent is constructed of a physician and product manuals library may. The law restricts these devices to sale by or on the order of a physician on any information do. All rights reserved Topics ; Home ; help ( full/part words ) This site Exclusively! Property of their respective owners n 2023 Boston Scientific Corporation or its affiliates Cody.... Against another political party Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com you need whether. N First ; Previous ; Safety Topic / Subject Double Pigtail Ureteral Hydrophilic! Sponsored by BRACCO Inc. and Frank G. Shellock, Ph.D. All rights reserved First Time Baby. Rely on any information herein do so at their own risk only in countries with health. 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First; Previous; Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. WebAccessGUDID - Advanix Biliary (08714729787259)- Biliary Stent with NaviFlexTM RX Delivery System. 0000002030 00000 n
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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. Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging i@@ -n0 i+ vy+=,%4>pV 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. 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
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. 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
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. 0000060763 00000 n
To aid in placement, the stent is constructed of a flexible yet durable polymer. xb```a``a`c`ed@ A;P]\6GzM2F8l2/NK8|V7e"KVf '- 4000 Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION.
To aid in placement, the stent is constructed of a flexible yet durable polymer. Polymeric biliary stent, non-bioabsorbable. 0000032476 00000 n
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FEATURE INTENDED BENEFIT Maximized Lumenal Integrity WebIf you are placing a plastic stent, why choose an Advanix Stent? 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. 0000023052 00000 n
This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. 0000008918 00000 n
l3"Ll
lmdE~k+fdN 0000194996 00000 n
Version or Model: M00534340.
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. 0000061111 00000 n
Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. 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. 0000004871 00000 n
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Request Information Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details 0000002605 00000 n
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GMDN Names and Definitions: Copyright GMDN Agency 2015. Commercial Distribution Status: In Commercial Distribution. 0000001521 00000 n
Commercial Distribution End Date: Device Count: 1. Advanix Duodenal Bend Preloaded RX Stent Systems 0000002905 00000 n
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Commercial Distribution Status: In Commercial Distribution. 0000051562 00000 n
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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.
Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 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, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. 0000003127 00000 n
Indications, Safety, and Warnings. 0000006218 00000 n
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 `abi` 2"Hb? Available in a variety of French sizes and lengths. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency.
MR imaging within these conditions may be performed immediately following the implantation of the stent. 0000001945 00000 n
First; Previous; Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! 1.5, 3. First; Previous; Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 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. 0000003307 00000 n
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