59-0034-02
59-0034-02 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K112671 on 4 May 2012 (1 earlier submission) and listed in FDA GUDID since 12 Jul 2016 (UDI-DI 00841036211233), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841036211233 | Date12 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112671 | Date4 May 2012 | StatusActive |
Official records
- AccessGUDID record 00841036211233
- FDA 510(k) database K112671
- FDA 510(k) database K062510
Across registries
- FDA 510(k) K112671 decided 4 May 2012 Active
- FDA GUDID UDI-DI 00841036211233 listed 12 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K062510
- Cleared FDA 510(k) K112671
- Listed FDA GUDID 00841036211233
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Device sterilization/disinfection container, reusable
- Model / Ref / Catalog
- 59-0034-02
- Primary DI / UDI-DI
- 00841036211233
- FDA product code
- FRG, KCT
- GMDN term
- Device sterilization/disinfection container, reusable
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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