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2.4mm Volar Distal Radius Removal Driver
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 925 (AR-8924VD-S)Model 926 (AR-8924VT-S)
Identity
- Trade Name
- 2.4mm Volar Distal Radius Removal Driver EUDAMEDArthrex FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- 2.4mm Volar Distal Radius Trial Plates EUDAMED
- Model / Reference
- 926 (AR-8924VT-S) EUDAMED925 (AR-8924VD-S) EUDAMED2.4 mm Volar Distal Radius Removal Driver FDA UDI
Identifiers
- Catalog Number
- AR-8924VD-S FDA UDI
- Primary DI / UDI-DI
- 00857676008195 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857676008RA958674 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
2.4mm Volar Distal Radius Removal Driver by Eca Medical Instruments — Class IIa — 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 | 0857676008RA958674 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Eca Medical Instruments
- EUDAMED SRN
- US-MF-000010686
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 811a34fc-6696-4742-96df-a9f767ee35fb 61 fields · synced Jul 17, 2026
- FDA UDI 6839da4b-9fcf-4425-8960-a7af88b1f19f 33 fields · synced May 30, 2026