INSIGHT Lateral Access Blade Curved Straight Narrow Wide Long Medium Short Blade Extension Blade Holder Winglet
Ref 03.816.050Model INSIGHT Lateral Access Blade
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 | Number7611819a00448JY 07611819518773 | 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- Withdrawn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
- INSIGHT Lateral Access Blade Curved Straight Narrow Wide Long Medium Short Blade Extension Blade Holder Winglet
- Model / Reference
- INSIGHT Lateral Access Blade, 03.816.050
- Primary DI / UDI-DI
- 07611819518773
- Basic UDI-DI
- 7611819a00448JY
- Direct Marketing DI
- 07611819518773
- 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 (13)
- Sterile: No
- 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