Single Use Instruments Spine Threaded Rod Perforated Schanz Screws
by Synthes GmbH
Ref 03.627.621SModel Single Use Instruments Threaded Rod
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00776KL 07611819504110 | Date11 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Single Use Instruments Spine Threaded Rod Perforated Schanz Screws
- Model / Reference
- Single Use Instruments Threaded Rod, 03.627.621S
- Primary DI / UDI-DI
- 07611819504110
- Basic UDI-DI
- 7611819a00776KL
- EMDN Code
- Z12139099 Various orthopaedic and traumatology instruments - other
- Device Class
- Class IIa
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- 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