Mallet Trocar Shaver
Ref 389.743, 389.744, 389.741, 387.002, 389.747, 389.746Model Cervical Cages Osteosynthesis Reusable Instruments
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 | Number7611819a00179JU | Date14 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- Withdrawn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
- Mallet Trocar Shaver
- Model / Reference
- Cervical Cages Osteosynthesis Reusable Instruments, 389.743, 389.744, 389.741, 387.002, 389.747, 389.746
- Primary DI / UDI-DI
- 07611819816084, 07611819816091, 07611819816060, 07611819103559, 07611819816121, 07611819816114
- Basic UDI-DI
- 7611819a00179JU
- Direct Marketing DI
- 076118198160840761181981609107611819816060076118191035590761181981612107611819816114
- EMDN Code
- L091099 Osteosynthesis instruments, reusable - other
- Device Class
- Class I
- 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 (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No