FDA-Device2020-11-04Class II
Instructions For Use document of the GPS Trackers.
Blue Ortho
Hazard
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Sold states
Domestic Distribution Only: CA, CO, SC and WI.
Affected count
3471 units
Manufactured in
6 Allee De Bethleem, N/A, Gieres, N/A, France
Products
Instructions For Use document of the GPS Trackers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2021Don't want to check this manually?
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