2.4mm Volar Distal Radius Trial Plates
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- 2.4mm Volar Distal Radius Trial Plates EUDAMEDArthrex FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 2.4mm Volar Distal Radius Trial Plates EUDAMED
- Model / Reference
- 926 (AR-8924VT-S) EUDAMED2.4 mm Volar Distal Radius Plate Template FDA UDI
Identifiers
- Catalog Number
- AR-8924VT-S FDA UDI
- Primary DI / UDI-DI
- 00857676008188 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
- Orthopaedic surgical procedure kit, non-medicated, 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Joint prosthesis implantation kit, single-use
2.4mm Volar Distal Radius Trial Plates by Eca Medical Instruments — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 91d48b09-5766-45fb-b788-660c9071d4f7 61 fields · synced Jun 19, 2026
- FDA UDI 40fab34b-51bd-4f7d-931c-83ce32b5a38e 33 fields · synced May 30, 2026