Sterilization Box Cohe 04
by S.I.N. - Sistema DE Implante Nacional S.A.
Sterilization Box Cohe 04 is a Class II device made by S.I.N. - Sistema DE Implante Nacional S.A., cleared under FDA 510(k) K201688 on 21 Oct 2020 and listed in FDA GUDID since 24 Mar 2021 (UDI-DI 07899995294111), 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 | Number07899995294111 | Date24 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201688 | Date21 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 07899995294111
- FDA 510(k) database K201688
Across registries
- FDA 510(k) K201688 decided 21 Oct 2020 Active
- FDA GUDID UDI-DI 07899995294111 listed 24 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K201688
- Listed FDA GUDID 07899995294111
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sterilization Box
- Generic name
- Instrument transport trolley system
- Model / Ref / Catalog
- COHE 04
- Primary DI / UDI-DI
- 07899995294111
- 510(k) Number
- FDA product code
- KCT
- GMDN term
- Instrument transport trolley system
- 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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