Device product
CustMbite, Model Number CBT-SRS-UL
Z-1494-2022
Product summary
- Event
- Event 90639
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 708
- Official record key
device-enforcement:Z-1494-2022
Official wording
Reason: The device was marketed and sold in the US without FDA clearance.
Code information: UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The device was marketed and sold in the US without FDA clearance.