Identity
- Trade Name
- Gelbke Cobb Elevator with Suction EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Retractor EUDAMEDGelbke Cobb Elevator with Suction FDA UDI
- Model / Reference
- 3433 EUDAMEDFDA UDI
- Description
- Gelbke Cobb Elevator with Suction FDA UDI
Identifiers
- Catalog Number
- 3433 FDA UDI
- Primary DI / UDI-DI
- 00840277123077 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277123077 EUDAMED
- FDA Product Code
- HTE FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gelbke Cobb Elevator with Suction by Innomed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNORETRACT016A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 13f15686-ce0c-4222-afdf-545fc81faf8d 61 fields · synced Aug 3, 2026
- FDA UDI 6d8081d1-a472-456a-a068-9b44aa8beb31 34 fields · synced May 30, 2026