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-8.5 EUDAMEDG21661 FDA UDI
- Description
- Soehendra Stent Retriever FDA UDI
Identifiers
- Catalog Number
- SSR-8.5 FDA UDI
- Primary DI / UDI-DI
- 00827002216617 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002216617 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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903420 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K161203 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00827002216617 | Class I | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED afe4845f-7572-42c8-97ab-de7d0b5fc601 61 fields · synced Jun 19, 2026
- FDA UDI a71102b6-aaff-4137-be45-3aebb85a7442 36 fields · synced May 30, 2026
- FDA 510(k) K903420 1 fields · synced May 18, 2026