iotaSOFT Insertion System

GUDID 00850002960006

iotaSOFT Drive Unit

Iotamotion, Inc.

Robotic surgical system application software

• Primary Device ID: 00850002960006
• NIH Device Record Key: 98dab9f4-49ac-4513-af97-4d39fb2548df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iotaSOFT Insertion System
• Version Model Number: IM-00
• Company DUNS: 080053045
• Company Name: Iotamotion, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002960006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190055

FDA Product Code

• QQH: Powered Insertion System For A Cochlear Implant Electrode Array

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-30
• Device Publish Date: 2024-09-20

On-Brand Devices [iotaSOFT Insertion System]

• 00850002960068: iotaSOFT Plus Drive Unit
• 00850002960051: iotaSOFT Control Console
• 00850002960044: iotaSOFT Rolling Stand
• 00850002960037: iotaSOFT Footpedal
• 00850002960020: iotaSOFT Console
• 00850002960006: iotaSOFT Drive Unit