Identity
- Trade Name
- Lewin Small Bone Clamp 5" EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- Forceps EUDAMEDLewin Small Bone Clamp 5" FDA UDI
- Model / Reference
- 4685 EUDAMEDFDA UDI
- Description
- Lewin Small Bone Clamp 5" FDA UDI
Identifiers
- Catalog Number
- 4685 FDA UDI
- Primary DI / UDI-DI
- 00840277108227 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOFORCEP01TM EUDAMED
- Direct Marketing DI
- 00840277108227 EUDAMED
- FDA Product Code
- HXD FDA UDI
- EMDN Code
- L091399 ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone approximation clamp 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
Lewin Small Bone Clamp 5" 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 | 8402771INNOFORCEP01TM | 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 10f43264-5b3c-4f92-b108-4e45fac75c62 61 fields · synced Jun 19, 2026
- FDA UDI af25c339-e3f5-4a2c-aa96-ce15b464f979 34 fields · synced May 30, 2026