Sterlink™ CD42
Sterlink™ CD42 is a Class II device made by Plasmapp Co., Ltd., cleared under FDA 510(k) K212193 on 22 Oct 2021 and listed in FDA GUDID since 26 Nov 2021 (UDI-DI 08800066500191), 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 | Number08800066500191 | Date26 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212193 | Date22 Oct 2021 | StatusActive |
Official records
- AccessGUDID record 08800066500191
- FDA 510(k) database K212193
Across registries
- FDA 510(k) K212193 decided 22 Oct 2021 Active
- FDA GUDID UDI-DI 08800066500191 listed 26 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K212193
- Listed FDA GUDID 08800066500191
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sterlink™
- Generic name
- Chemical/physical sterilization process indicator
- Model / reference
- CD42
- Primary DI / UDI-DI
- 08800066500191
- 510(k) Number
- FDA product code
- JOJ, FRC
- 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.