Identity
- Trade Name
- NEOFUSE EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Instruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDDIAM 4.5 MM SCREW DRILL GUIDE FDA UDI
- Model / Reference
- P02 00151 EUDAMEDFDA UDI
- Description
- DIAM 4.5 MM SCREW DRILL GUIDE FDA UDI
Identifiers
- Catalog Number
- P02 00151 FDA UDI
- Primary DI / UDI-DI
- 03760225717097 EUDAMEDFDA UDI
- Basic UDI-DI
- 37013376410773 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDI
Category: Wire holding/twisting forceps
Neofuse by In2Bones SAS — Class I — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37013376410773 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED e902a06b-84a8-4425-9633-5379b38b38fb 61 fields · synced Jun 18, 2026
- FDA UDI 4b8f96b8-f42a-49c9-8496-ab99a376f907 36 fields · synced May 30, 2026
- EUDAMED 34903b84-34ec-47ff-913a-a17c6bd66c4c 61 fields · synced Jun 11, 2026