Identity
- Trade Name
- NEOFUSE EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- PERCUTANEOUS BURRS EUDAMEDT15 SCREWDRIVER TIP NO CANULATED FDA UDI
- Model / Reference
- G01 00351 EUDAMEDFDA UDI
- Description
- T15 SCREWDRIVER TIP NO CANULATED FDA UDI
Identifiers
- Catalog Number
- G01 00351 FDA UDI
- Primary DI / UDI-DI
- 03760225717158 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225717158 EUDAMED
- 510(k) Number
- K173121 FDA UDI
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 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
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
Neofuse by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-03760225717158 | 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 0f9af5cb-f41a-41c2-9b60-c92121e3b82c 61 fields · synced Jun 19, 2026
- FDA UDI e4c38f1b-fcf2-4f19-b5e2-d253597e31e2 36 fields · synced May 30, 2026
- EUDAMED 355f767a-85fb-49b0-b437-c03ebb5a10fe 61 fields · synced Jun 19, 2026