Holder Bone Graft Packing Prep Tamp Torque Limiting Handle Spreader Top Endplate Removal Tool Screwdriver Release Tool Spreader Top Shaft
Ref 03.807.351Model XRL Instruments for Insertion and Extraction
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 | Number7611819a00168JP 07611819406315 | Date10 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- Withdrawn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
- Holder Bone Graft Packing Prep Tamp Torque Limiting Handle Spreader Top Endplate Removal Tool Screwdriver Release Tool Spreader Top Shaft
- Model / Reference
- XRL Instruments for Insertion and Extraction, 03.807.351
- Primary DI / UDI-DI
- 07611819406315
- Basic UDI-DI
- 7611819a00168JP
- Direct Marketing DI
- 07611819406315
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- 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