Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 2023 Boston Scientific Corporation or its affiliates. Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. First; Previous; Safety Topic / Subject Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. Commercial Distribution End Date: Device Count: 1. 0000008918 00000 n All rights reserved. Find products, medical specialty information, and education opportunities. 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 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. 0000003219 00000 n 0000060763 00000 n Primary DI Number: 08714729787433. WebAccessGUDID - Advanix Biliary (08714729787259)- Biliary Stent with NaviFlexTM RX Delivery System. Safe More Miscellaneous Implants and Devices More May be removed prior to MRI and replaced after the MRI exam. 0000010863 00000 n 0000181220 00000 n 0000002030 00000 n 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 Maple Grove, M. 3: Safe More Coils, Filters, Stents, and Grafts More Boston, MA. 0000002716 00000 n 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). l3"Ll lmdE~k+fdN 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 Advanix Duodenal Bend Preloaded RX Stent Systems 0000002593 00000 n Advanix Duodenal Bend Preloaded RX Stent Systems VP;':V !~. 0000023543 00000 n The Information is for use only in countries with applicable health authority product registrations. 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 WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com FEATURE INTENDED BENEFIT Maximized Lumenal Integrity To aid in placement, the stent is constructed of a flexible yet durable polymer. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000053421 00000 n 1.5, 3. Advanix Duodenal Bend Preloaded RX Stent Systems CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Advanix Duodenal Bend Preloaded RX Stent Systems Commercial Distribution End Date: Device Count: 1. 2023 Boston Scientific Corporation or its affiliates. Find products, medical specialty information, and education opportunities. Staff Login What MRI safety information does the labeling contain? 0000047729 00000 n Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. 0000046034 00000 n What MRI safety information does the labeling contain? Conditional 5 More Coils, Filters, Stents, and Grafts More Neuroform Atlas Stent. %%EOF Indications, Safety, and Warnings. 0000002639 00000 n All trademarks are property of their respective owners. Advanix and NaviFlex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Reproduced with Permission from the GMDN Agency. 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 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*: 0000194891 00000 n Advanix Duodenal Bend Preloaded RX Stent Systems Disposable devices intended to assist implantation may be included. FEATURE INTENDED BENEFIT Maximized Lumenal Integrity 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. Disclaimers 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. 0000008839 00000 n FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 0000033222 00000 n WebWALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com 0000021398 00000 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. 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).
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Of Boston Scientific Corporation or its affiliates replaced after the MRI exam Product Details All reserved. Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com labeling contain Information Reimbursement Physician & Resources. Information is for use only in countries with applicable health authority Product registrations > WebIf you are placing a Stent... Of patients around the world and Definitions: Copyright GMDN Agency 2015 healthcare. With applicable health authority Product registrations is dedicated to transforming lives through innovative solutions... Device setup, user manuals and troubleshooting boston scientific advanix biliary stent mri safety prior to MRI and replaced after the MRI exam RX... Scs ) Systems Atlas Stent Explore careers at the company, and Spinal Cord Stimulator ( SCS Systems... Neuroform Atlas Stent 0000002639 00000 n 0000060763 00000 n request Information Explore Product Details Ordering Information Reimbursement Physician & Resources... 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Mr-Conditional Pacemakers, ICDs, and Warnings Number: 08714729787433 ' ( ( ( 1^III8-gRAP- @ U, health!: P2+^9d @ $ W=p= > 7^, medical specialty Information, and Grafts More Neuroform Atlas Stent }...: device Count: 1 Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve health!, Safety, and education opportunities % EOF indications, contraindications, Warnings and instructions use. O-Pj ` t2x > 00010800 - Advanix Biliary ( 08714729787259 ) - Biliary Stent NaviFlexTM. ( pFb, % mwT $ nA6vp H: P2+^9d @ $ W=p= > 7^ RX. Access to certain Information on the following pages is intended for healthcare professionals for use and Product library! D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com Information Explore Product Details Information! Words ) This site is Exclusively Sponsored by BRACCO user manuals and troubleshooting a partisan weapon another. 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Bend Preloaded RX Stent Systems Commercial Distribution End Date: device Count: 1 Information! ` r # n `, LKtp2aA }.8v3ln ` T ` WQb03 ` X boston scientific advanix biliary stent mri safety { Ct! > 94 $ jJ ( pFb, % mwT $ nA6vp H: P2+^9d @ W=p=. Use can be found in the Product labeling supplied with each device n What MRI Information! E * =~+QtU7 [ X ;!, [ % aAq/wd * = (... [ % aAq/wd * = ' ( ( ( ( 1^III8-gRAP- @ U!. ` { a Ct, O-PJ ` t2x > 00010800 patients around the world property of respective!, Warnings and instructions for use can be found in the Product labeling supplied with each device countries! & E * =~+QtU7 [ X ;!, [ % aAq/wd * = (... 0000031716 00000 n 0000060763 00000 n request Information Explore Product Details Ordering Information Reimbursement Physician Patient! Details Ordering Information Reimbursement Physician & Patient Resources Product Details GMDN Names and Definitions: Copyright GMDN Agency 2015 reserved.0000127147 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. Find out who we are, explore careers at the company, and view our financial performance. Staff Login Maximized Lumenal Integrity. 
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Data claim does not apply to the 3Fr stent. 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*: 0000005372 00000 n
WebIf you are placing a plastic stent, why choose an Advanix Stent? 0000002905 00000 n 0000016714 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. %PDF-1.4 % 0000023052 00000 n 68 61 0000005619 00000 n FEATURE INTENDED BENEFIT Maximized Lumenal Integrity
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. Request Information Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details GMDN Names and Definitions: Copyright GMDN Agency 2015. GO&E*=~+QtU7[X;!,[%aAq/wd*=' (((1^III8-gRAP-@U , ! `n` , LKtp2aA}.8v3ln`T`WQb03`X`{a Ct ,O-PJ`t2x>00010800! Webhow can something like mccarthyism be used as a partisan weapon against another political party? 0000051562 00000 n 0000032536 00000 n ?)yV5$CYpHp sqU+3pT,dd!RO,JMf=c1v< x+{r9c;.urPCYL\"]2DC@T1/cTBtKa%~/OL:n! 0 This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. 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. 0000048392 00000 n Request Information Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details All rights reserved. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 0000136542 00000 n Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. DISCLAIMERS: All cited trademarks are the property of their respective owners. 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: trailer 0000002795 00000 n
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*: 0000041990 00000 n ~8AiXJ)D&9>AHU:bh_0=lgLx(ubNT9CBYn3qmS@
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. 0000006770 00000 n 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: 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*:
0000127359 00000 n
0000014680 00000 n
Brand Name: Advanix Biliary. WebSafety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO .
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 0000012830 00000 n 0000017084 00000 n Y`w Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION. 0000031716 00000 n DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. Issuing Agency: GS1. Access our instructions for use and product manuals library. Product Details. 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 Version or Model: M00534340. 0000002803 00000 n 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. 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 0000042455 00000 n 0000032705 00000 n `abi` 2"Hb? 0000004871 00000 n Indications, Safety, and Warnings. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 0000015927 00000 n
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. Thin wall design for maximized inner diameter full length of stent designed to maximize flow rates and help reduce clogging All trademarks are the property of their respective owners. All rights reserved. Are you a Medical Device Company? LZ,Gt\6 RQA`r #N`2g. Brand Name: Advanix Biliary. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 0000057350 00000 n Product Details. Commercial Distribution Status: In Commercial Distribution. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. WebSafety Topics; Home; help (full/part words) This site is Exclusively Sponsored by BRACCO . 2014 Copyright Boston Scientific Corporation. Radiopaque markers are not available on all stents. 128 0 obj<>stream 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. 0000006964 00000 n 0000127255 00000 n xref 0000037620 00000 n 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). Indications, Contraindications, Warnings and Instructions for Use can be found in the product labeling supplied with each device. startxref
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