MatrixPRO II 90-Degree Collet, Long
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- MatrixPRO II 90-Degree Collet, Long EUDAMEDMatrix Pro II 90D Collet, long FDA UDI
- Generic Name
- Screwing power tool attachment FDA UDI
- Device Name
- Collet Attachment EUDAMEDMatrixPRO II 90-Degree Collet, Long EUDAMED
- Model / Reference
- APD-CA-XXX EUDAMED03.000.503 EUDAMEDFDA UDIAPD-CA-102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856482008092 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856482008APD-CAZH EUDAMEDB-00856482008092 EUDAMED
- Direct Marketing DI
- 00856482008092 EUDAMED
- FDA Product Code
- HWE FDA UDIGEY FDA UDIGXL FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Screwing power tool attachment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- 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 90-Degree Collet, Long by Pro-Dex, Inc. — Class I — MDD, MDR, 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
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- 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/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0856482008APD-CAZH | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0856482008APD-CAZH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b4f21411-5d86-4df2-8ffe-202f70e75da4 61 fields · synced Jul 10, 2026
- EUDAMED 8e32795e-bb0e-486a-a466-6bd7bb007f2c 61 fields · synced May 19, 2026
- FDA UDI b3ab4960-5f1d-4c6b-8ff4-b0966ac8e611 32 fields · synced May 30, 2026