Identity
- Trade Name
- PRO-DEX Surgical Driver EUDAMEDPro-Dex Surgical Driver AO Collet FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- PRO-DEX Surgical Driver EUDAMED
- Model / Reference
- PDSD-5000-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856482008214 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856482008214 EUDAMED
- FDA Product Code
- GEY FDA UDIGXL FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4900 FDA UDI
- Market of Registration
- Finland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
PRO-DEX Surgical Driver by Pro-Dex, Inc. — Class IIa — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00856482008214 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Pro-Dex, Inc.
- EUDAMED SRN
- US-MF-000010685
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED 5580c471-6e89-467c-af99-a98d755a865e 61 fields · synced Sep 18, 2026
- FDA UDI ef3a2208-20b9-4a30-9902-ff1c63d908aa 32 fields · synced May 30, 2026