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12" Premier EZ-Clean Driver - AO Synthes
EUDAMEDClass I (EU MDR)
Ref 200-153-00
Identity
- Trade Name
- 12" Premier EZ-Clean Driver - AO Synthes EUDAMED
- Device Name
- Quick-Coupling Handle for Flexible Osteotomes EUDAMED
- Model / Reference
- 200-153-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847538006186 EUDAMED
- Basic UDI-DI
- 084753804782954 EUDAMED
- Direct Marketing DI
- 00847538006186 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
12" Premier EZ-Clean Driver - AO Synthes by Symmetry Medical Manufacturing, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084753804782954 | Class I | Active |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (1)
- EUDAMED 46c87944-9df3-4ae9-b961-8ea795184b24 61 fields · synced Jun 18, 2026