MatrixPRO II J-Latch Collet
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- MatrixPRO II J-Latch Collet EUDAMEDMatrix Pro II J-latch collet FDA UDI
- Generic Name
- Screwing power tool attachment FDA UDI
- Device Name
- MatrixPRO II J-Latch Collet EUDAMEDCollet Attachment EUDAMED
- Model / Reference
- APD-CA-002-2 EUDAMED03.000.501 EUDAMEDFDA UDIAPD-CA-XXX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856482008078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856482008078 EUDAMED0856482008APD-CAZH EUDAMED
- Direct Marketing DI
- 00856482008078 EUDAMED
- FDA Product Code
- HWE FDA UDIGXL FDA UDIGEY FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Screwing power tool attachment FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA 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
Single Use
No
Implantable
No
Reusable
Yes
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Surgical retraction system, reusable
MatrixPRO II J-Latch Collet by Pro-Dex, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00856482008078 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00856482008078 | 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 de3a82cf-ec7e-442f-867a-208f76a27a19 61 fields · synced Jul 26, 2026
- EUDAMED 9c1f3e46-8068-443c-aa51-d8fdca56cfde 61 fields · synced May 17, 2026
- FDA UDI ea7bd0e7-4acb-4baa-bddd-9b1953c77b0a 32 fields · synced May 30, 2026