Shoulder Instruments 04.01.10.0647
Ref 04.01.10.0647
Shoulder Instruments 04.01.10.0647 is a Class I device made by Medacta International, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 764014274SSR0011N00GL) and listed in FDA GUDID since 2 Nov 2022 (UDI-DI 07630345745743), active as of 23 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 | Number764014274SSR0011N00GL 07630345745743 | Date2 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630345745743 | Date2 Nov 2022 | StatusListed |
Official records
- EUDAMED public site 764014274SSR0011N00GL
- AccessGUDID record 07630345745743
Across registries
- EUDAMED Basic UDI-DI 764014274SSR0011N00GL registered 2 Oct 2026 Active
- FDA GUDID UDI-DI 07630345745743 listed 2 Nov 2022 Listed
Timeline
- Listed FDA GUDID 07630345745743
- Registered EUDAMED 764014274SSR0011N00GL
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- GRS glenosphere guide EUDAMEDShoulder Instruments GUDID
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device name
- Shoulder Alignment guide / Insertion guide
- Model / reference
- 04.01.10.0647
- Primary DI / UDI-DI
- 07630345745743
- Basic UDI-DI
- 764014274SSR0011N00GL
- FDA product code
- LXH
- EMDN code
- L0922 Orthopaedic surgery guides, reusable
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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