Surgical Instrument 112-168
Surgical Instrument 112-168 is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K221412 on 22 Nov 2022 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 08800089434138), 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 | Number08800089434138 | Date7 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221412 | Date22 Nov 2022 | StatusActive |
Official records
- AccessGUDID record 08800089434138
- FDA 510(k) database K221412
Across registries
- FDA 510(k) K221412 decided 22 Nov 2022 Active
- FDA GUDID UDI-DI 08800089434138 listed 7 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K221412
- Listed FDA GUDID 08800089434138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surgical Instrument
- Generic name
- Device sterilization/disinfection container, reusable
- Model / reference
- 112-168
- Primary DI / UDI-DI
- 08800089434138
- 510(k) Number
- FDA product code
- 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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