Identity
- Trade Name
- Flexxus® Endoscopic Biliary Stent FDA UDI
- Generic Name
- Bare-metal biliary stent FDA UDI
- Device Name
- Flexxus® Endoscopic Biliary Stent, 10 mm x 40 mm (190cm deployment system) FDA UDI
- Model / Reference
- LXB10040 FDA UDI
- Description
- Flexxus® Endoscopic Biliary Stent, 10 mm x 40 mm (190cm deployment system) FDA UDI
Identifiers
- Catalog Number
- LXB10040 FDA UDI
- Primary DI / UDI-DI
- 00801741099274 FDA UDI
- 510(k) Number
- K031186 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Bare-metal biliary stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
MR Safe FDA UDI
Flexxus® Endoscopic Biliary Stent by Angiomed GmbH & Co. Medizintechnik KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angiomed GmbH & Co. Medizintechnik KG
Sources (1)
- FDA UDI 5ff1ee44-fc88-43f9-bee5-d27f7dee55dc 38 fields · synced Jun 1, 2026