FDA-Device2021-06-30Class II
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
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
3000 units
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1919-2021Don't want to check this manually?
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