FDA-Device2020-01-29Class II
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Acclarent, Inc.
Hazard
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Sold states
US: WI, IL, NE, CA, OH, NY OUS: None
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2020Don't want to check this manually?
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