Sterim SBI-100
Sterim SBI-100 is a Class II device made by True Indicating LLC, cleared under FDA 510(k) K200970 on 28 Dec 2020 and listed in FDA GUDID since 28 Apr 2023 (UDI-DI 00197644533428), 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 | Number00197644533428 | Date28 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200970 | Date28 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 00197644533428
- FDA 510(k) database K200970
Across registries
- FDA 510(k) K200970 decided 28 Dec 2020 Active
- FDA GUDID UDI-DI 00197644533428 listed 28 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K200970
- Listed FDA GUDID 00197644533428
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sterim
- Generic name
- Biological sterilization indicator
- Model / Ref / Catalog
- SBI-100
- Primary DI / UDI-DI
- 00197644533428
- 510(k) Number
- FDA product code
- FRC
- GMDN term
- Biological sterilization indicator
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution
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