Device product
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Z-1920-2021
Product summary
- Event
- Event 87958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78000 units
- Official record key
device-enforcement:Z-1920-2021
Official wording
Reason: No 510k for the product to be used in a natural or surgical opening to the body
Code information: Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028
Distribution pattern: US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Derived failure modes
-
Unknown
No 510k for the product to be used in a natural or surgical opening to the body