Identity
- Trade Name
- WallFlex™ FDA UDI
- Generic Name
- Polymer-metal biliary stent, non-bioabsorbable FDA UDI
- Device Name
- Stent System FDA UDI
- Model / Reference
- M00547500 FDA UDI
- Description
- Stent System FDA UDI
Identifiers
- Catalog Number
- M00547500 FDA UDI
- Primary DI / UDI-DI
- 00191506044480 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Polymer-metal biliary stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Length — 60 Millimeter FDA UDIStent Diameter — 8 Millimeter FDA UDI
Category: Polymer-metal biliary stent, non-bioabsorbable
WallFlex™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer-metal biliary stent, non-bioabsorbable.
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- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
- GORE VIABIL Biliary Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 5de85abb-3299-419f-9b5c-e30f111e367d 35 fields · synced Jun 8, 2026