Connecting Bar Position Retainer Push Button Handle Screwdriver Holder Reduction Tool Length Indicator Guide Persuader Counter Torque Release Key Wrench Shaft Adapter Removal Instrument Sleeve Untightening Instrument Rod Indicator Slider
by Synthes GmbH EUDAMED
Active
Ref 03.628.113Model USS Fracture MIS Instruments for Insertion and Extraction
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00210HV | Date11 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- USS Fracture MIS Instruments for Insertion and Extraction, 03.628.113
- Primary DI / UDI-DI
- 07611819475991
- Basic UDI-DI
- 7611819a00210HV
- Direct Marketing DI
- 07611819475991
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- Device Class
- Class I
- 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