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iotaSOFT Insertion System
iotaSOFT Plus Drive Unit
Details
Device typeRobotic surgical system application software: An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical system typically used in computer assisted surgery (CAS) during orthopaedic procedures so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
FDA categoryPowered Insertion System For A Cochlear Implant Electrode Array
Device ID00850002960068
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Unsafe