Attest™ 390G
by 3M Company
Attest™ 390G is a Class II device made by 3M Company, cleared under FDA 510(k) K123546 on 18 Mar 2013 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 50707387767148), 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 | GUDID listing | Number50707387767148 | Date13 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123546 | Date18 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 50707387767148
- FDA 510(k) database K123546
Across registries
- FDA 510(k) K123546 decided 18 Mar 2013 Active
- FDA GUDID UDI-DI 50707387767148 listed 13 Oct 2016 Listed
Recalls
-
- Terminated Z-2002-2014
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
Timeline
- Cleared FDA 510(k) K123546
- Recall initiated FDA recalls Z-2002-2014
- Listed FDA GUDID 50707387767148
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Attest™
- Generic name
- Biological sterilization indicator reader
- Model / Ref / Catalog
- 390G
- Primary DI / UDI-DI
- 50707387767148
- FDA product code
- FRC
- GMDN term
- Biological sterilization indicator reader
- Device class
- Class II
- Regulation number
- 880.2800
- GUDID distribution status
- In Commercial Distribution