Identity
- Trade Name
- DuaFit® EUDAMEDFDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Instruments, orthopaedic surgeries of the upper and lower extremities EUDAMEDDUAFIT IMPLANT HOLDER 17° FDA UDI
- Model / Reference
- A06 00051 EUDAMEDFDA UDI
- Description
- DUAFIT IMPLANT HOLDER 17° FDA UDI
Identifiers
- Catalog Number
- A06 00051 FDA UDI
- Primary DI / UDI-DI
- 03760225715796 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337641006M EUDAMED
- FDA Product Code
- HWR FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
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
Yes
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
DuaFit® by In2Bones SAS — 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 | 3701337641006M | 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 (2)
- EUDAMED 4686318c-bb97-4e35-aae8-47999b60e7a9 61 fields · synced May 30, 2026
- FDA UDI 0363ad52-52f1-4cca-b6e5-a8f48b7fdd0b 35 fields · synced May 30, 2026