Identity
- Trade Name
- MatrixPRO Driver EUDAMEDMatrixPRO Driver Handpiece EUDAMEDFDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- MatrixPRO Driver EUDAMED
- Model / Reference
- SYN-1000 EUDAMED05.000.020 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862377000102 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00862377000102 EUDAMED0856482008SYN-1000SC 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
- 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
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
MatrixPRO Driver by Pro-Dex, Inc. — Class IIa — MDR, 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/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00862377000102 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00862377000102 | 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 (3)
- EUDAMED 16e9d911-9367-4b12-81e0-f1960a2e9636 61 fields · synced Jun 19, 2026
- EUDAMED 1a5ec42e-0c0e-4158-a7c2-536e6c2c7788 61 fields · synced May 18, 2026
- FDA UDI 75eb80a9-5e9e-4c8e-a639-cfccb1068bf3 32 fields · synced May 30, 2026