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.
Incorrect GTIN number.
Distribution was made to Iowa. There was no government/military/foreign distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2025