Paradigm 1200007
by Proprio
Paradigm 1200007 is a Class II device made by Proprio, cleared under FDA 510(k) K222291 on 21 Apr 2023 and listed in FDA GUDID since 5 May 2023 (UDI-DI 00850042604038), active as of 22 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 | Number00850042604038 | Date5 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222291 | Date21 Apr 2023 | StatusActive |
Official records
- AccessGUDID record 00850042604038
- FDA 510(k) database K222291
Across registries
- FDA 510(k) K222291 decided 21 Apr 2023 Active
- FDA GUDID UDI-DI 00850042604038 listed 5 May 2023 Listed
Timeline
- Cleared FDA 510(k) K222291
- Listed FDA GUDID 00850042604038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Paradigm
- Generic name
- Device sterilization/disinfection container, reusable
- Model / Ref / Catalog
- 1200007
- Primary DI / UDI-DI
- 00850042604038
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Device sterilization/disinfection container, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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