Cannulated Screw System + 04.353.770
Ref 04.353.770
Cannulated Screw System + 04.353.770 is a device classified as Class IIb in the EU and Class II in the US made by Tyber Medical, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 01964490165B) and listed in FDA GUDID since 8 May 2020 (UDI-DI 00810040638442), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01964490165B 00810040638442 | Date16 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810040638442 | Date8 May 2020 | StatusListed |
Official records
- EUDAMED public site 01964490165B
- AccessGUDID record 00810040638442
Across registries
- EUDAMED Basic UDI-DI 01964490165B registered 16 Mar 2026 Active
- FDA GUDID UDI-DI 00810040638442 listed 8 May 2020 Listed
Timeline
- Listed FDA GUDID 00810040638442
- Registered EUDAMED 01964490165B
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Cannulated Screw System +
- Generic name
- Orthopaedic bone screw (non-sliding)
- Device name
- Screws
- Model / Ref / Catalog
- 04.353.770
- Primary DI / UDI-DI
- 00810040638442
- Basic UDI-DI
- 01964490165B
- FDA product code
- HWC
- EMDN code
- P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 888.3040
- EU registration type
- Standard device
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |