FDA-Device2024-11-13Class III
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
Iotamotion Inc
Hazard
Incorrect GTIN number.
Sold states
Distribution was made to Iowa. There was no government/military/foreign distribution.
Affected count
5 devices
Manufactured in
4205 White Bear Pkwy Ste 600, N/A, Vadnais Heights, MN, United States
Products
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2025Don't want to check this manually?
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