FDA-Device2021-06-30Class II
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Exact Medical Manufacturing, Inc.
Hazard
No 510k for the product to be used in a natural or surgical opening to the body
Sold states
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Affected count
51300 units
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1917-2021Don't want to check this manually?
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