MediChoice 58277
by Owens & Minor Distribution, Inc.
MediChoice 58277 is a Class I device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K233578 on 22 Mar 2024 (1 earlier submission) and listed in FDA GUDID since 18 Mar 2025 (UDI-DI 10885632436758), 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 | Number10885632436758 | Date18 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233578 | Date22 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 10885632436758
- FDA 510(k) database K233578
- FDA 510(k) database K131407
Across registries
- FDA 510(k) K233578 decided 22 Mar 2024 Active
- FDA GUDID UDI-DI 10885632436758 listed 18 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K131407
- Cleared FDA 510(k) K233578
- Listed FDA GUDID 10885632436758
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MediChoice
- Generic name
- Sterilization container mat
- Model / reference
- 58277
- Primary DI / UDI-DI
- 10885632436758
- FDA product code
- FSM
- GMDN term
- Sterilization container mat
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
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