Advanix™ Pancreatic Stent Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Advanix™ EUDAMEDAdvanix™ Pancreatic Stent Kit FDA UDI
- Generic Name
- Polymeric pancreatic stent, non-bioabsorbable FDA UDI
- Device Name
- Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers EUDAMEDPancreatic Stent Kit FDA UDI
- Model / Reference
- M00537540 EUDAMEDFDA UDI
- Description
- Pancreatic Stent Kit FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 08714729856313 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000270MX EUDAMED
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
- GMDN Term
- Polymeric pancreatic stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Polymeric pancreatic stent, non-bioabsorbable
Advanix™ Pancreatic Stent Kit by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 1a196a34-7a19-4ca9-9b42-6e1d31bd6a39 35 fields · synced Oct 8, 2026
- EUDAMED d280de1d-975e-429c-8c43-e7b3359a9db4 61 fields · synced Oct 8, 2026