Identity
- Trade Name
- Soehendra FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- SOEHENDRA STENT RETRIEVER EUDAMEDFDA UDI
- Model / Reference
- SSR-5 EUDAMEDG21934 FDA UDI
- Description
- Soehendra Stent Retriever FDA UDI
Identifiers
- Catalog Number
- SSR-5 FDA UDI
- Primary DI / UDI-DI
- 00827002219342 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002219342 EUDAMED
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- G03050199 DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - OTHER EUDAMED
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Soehendra Stent Retriever by Wilson-Cook Medical, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002219342 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (2)
- EUDAMED 480a768a-23d7-4375-b962-2df89dcfa1a9 61 fields · synced Jul 29, 2026
- FDA UDI 4e09fd6c-17ea-4945-a1a4-0fa7daa599e9 36 fields · synced May 25, 2026