Verify PCC038
Verify PCC038 is a Class II device made by Albert Browne, Ltd., cleared under FDA 510(k) K162758 on 21 Mar 2017 (1 earlier submission) and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 10724995088030), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162758 | Date21 Mar 2017 | StatusActive |
| United States | GUDID listing | Number10724995088030 | Date6 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 10724995088030
- FDA 510(k) database K162758
- FDA 510(k) database K071895
Across registries
- FDA 510(k) K162758 decided 21 Mar 2017 Active
- FDA GUDID UDI-DI 10724995088030 listed 6 Sep 2016 Listed
Recalls
-
- Terminated Z-1736-2022
Product contains incorrect chemical indicators in packaging.
Timeline
- Cleared FDA 510(k) K071895
- Listed FDA GUDID 10724995088030
- Cleared FDA 510(k) K162758
- Recall initiated FDA recalls Z-1736-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Verify
- Generic name
- Chemical/physical sterilization process indicator
- Model / Ref / Catalog
- PCC038
- Primary DI / UDI-DI
- 10724995088030
- FDA product code
- JOJ
- GMDN term
- Chemical/physical sterilization process indicator
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Chemical/physical sterilization process indicator.