Proximal Tibia Left Handle 2142-35-012
Ref 214235012
Proximal Tibia Left Handle 2142-35-012 (214235012) is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00887868444968) and listed in FDA GUDID since 10 Jul 2020 (UDI-DI 00887868444968), active as of 7 Nov 2026.
Active
CE MDD
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/MDD EUDAMED | NumberB-00887868444968 00887868444968 | Date24 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00887868444968 | Date10 Jul 2020 | StatusListed |
Official records
- EUDAMED public site B-00887868444968
- AccessGUDID record 00887868444968
Across registries
- EUDAMED Basic UDI-DI B-00887868444968 registered 24 Oct 2026 Active
- FDA GUDID UDI-DI 00887868444968 listed 10 Jul 2020 Listed
Timeline
- Listed FDA GUDID 00887868444968
- Registered EUDAMED B-00887868444968
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Proximal Tibia Left Handle
- Generic name
- Surgical instrument handle, non-torque-limiting
- Model / Ref / Catalog
- 214235012, 2142-35-012
- Primary DI / UDI-DI
- 00887868444968
- Basic UDI-DI
- B-00887868444968
- FDA product code
- LXH
- EMDN code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN term
- Surgical instrument handle, non-torque-limiting
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 214235012 | 2142-35-012 |
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