MARK3 6127CS
MARK3 6127CS is a Class II device made by Cargus International, Inc, cleared under FDA 510(k) K171823 on 22 Feb 2018 and listed in FDA GUDID since 22 Apr 2021 (UDI-DI D7966127CS1), 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 | NumberD7966127CS1 | Date22 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171823 | Date22 Feb 2018 | StatusActive |
Official records
- FDA 510(k) database K171823
Across registries
- FDA 510(k) K171823 decided 22 Feb 2018 Active
- FDA GUDID UDI-DI D7966127CS1 listed 22 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K171823
- Listed FDA GUDID D7966127CS1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MARK3
- Generic name
- Chemical/physical sterilization process indicator
- Model / reference
- 6127CS
- Primary DI / UDI-DI
- D7966127CS1
- 510(k) Number
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Chemical/physical sterilization process indicator.