Device product
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Z-1356-2021
Product summary
- Event
- Event 87581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
device-enforcement:Z-1356-2021
Official wording
Reason: Device was distributed without a proper marketing authorization.
Code information: All lots
Distribution pattern: World-wide distribution.
Derived failure modes
-
Unknown
Device was distributed without a proper marketing authorization.