FDA-Device2025-03-26Class II
CYSTO , Model No SACY80R
American Contract Systems Inc
Hazard
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Sold states
US Nationwide distribution in the state of OH.
Affected count
144 kits
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
CYSTO , Model No SACY80R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2025Don't want to check this manually?
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