FDA-Device2025-03-26Class II
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
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
170 kits
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2025Don't want to check this manually?
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