Device product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Z-0856-2022
Product summary
- Firm
- SA3, LLC
- Event
- Event 89687
- Status
- Terminated
- Classification
- Class II
- Quantity
- 156 units
- Official record key
device-enforcement:Z-0856-2022
Official wording
Reason: Due to failure of microbial testing for total aerobic microbial count (TAMC).
Code information: Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
Distribution pattern: U.S. Nationwide distribution in the states of CA, FL and GA.
Derived failure modes
-
Unknown
Due to failure of microbial testing for total aerobic microbial count (TAMC).