Identity
- Trade Name
- NEOFIT EUDAMEDFDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- NEOFIT MTP PLATING SYSTEM EUDAMEDNEOFIT TRIAL PLATE SIZE 40 MM FDA UDI
- Model / Reference
- P01 00241 EUDAMEDFDA UDI
- Description
- NEOFIT TRIAL PLATE SIZE 40 MM FDA UDI
Identifiers
- Catalog Number
- P01 00241 FDA UDI
- Primary DI / UDI-DI
- 03760225714126 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225714126 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wire holding/twisting forceps
Neofit by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-03760225714126 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED 2396cc3b-ef6a-4628-8460-fe1a35f8e521 61 fields · synced Jun 19, 2026
- FDA UDI 432473e4-d565-40f7-bca8-1a629db8287c 36 fields · synced May 29, 2026
- EUDAMED 391c1fcb-7b89-4704-9fbd-d11aceb8236a 61 fields · synced Jun 19, 2026