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Pointed Fracture Reduction Clamp Ratchet Curved
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3669
Identity
- Trade Name
- Pointed Fracture Reduction Clamp Ratchet Curved EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- Forceps EUDAMEDPointed Fracture Reduction Clamp with Ratchet FDA UDI
- Model / Reference
- 3669 EUDAMEDFDA UDI
- Description
- Pointed Fracture Reduction Clamp with Ratchet FDA UDI
Identifiers
- Catalog Number
- 3669 FDA UDI
- Primary DI / UDI-DI
- 00840277122377 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOFORCEP01TM EUDAMED
- Direct Marketing DI
- 00840277122377 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
Pointed Fracture Reduction Clamp Ratchet Curved 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 8461c266-3772-427b-8f4a-5e49e694c036 61 fields · synced Jun 19, 2026
- FDA UDI 0e611a00-36d6-4bdb-9988-dea1d6118491 34 fields · synced May 30, 2026