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MatrixPRO Driver Graphic Case Replacement Lid
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.000.011Model SYN-SCL-001
Identity
- Trade Name
- MatrixPRO Driver Graphic Case Replacement Lid EUDAMEDMatrixPro Sterilization Case Lid FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- MatrixPRO Driver Graphic Case Replacement Lid EUDAMEDGraphic Case EUDAMED
- Model / Reference
- SYN-SCL-001 EUDAMED60.000.011 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860540000218 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860540000218 EUDAMED0856482008SYN_APD-SC-XXHH EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
MatrixPRO Driver Graphic Case Replacement Lid by Pro-Dex, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860540000218 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-00860540000218 | 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 9b966e69-e5fb-40c3-8c3c-f815cb11a59a 61 fields · synced Jul 13, 2026
- EUDAMED a95ec15b-2aae-4a61-8617-f31ca7105284 61 fields · synced May 16, 2026
- FDA UDI 352343eb-dccf-4cc8-87ab-a8e1a50f9ef3 32 fields · synced May 30, 2026