iotaSOFT Insertion System

GUDID 00850002960037

iotaSOFT Footpedal

Iotamotion, Inc.

Robotic surgical system application software

• Primary Device ID: 00850002960037
• NIH Device Record Key: 305cbbd4-c9c9-46c1-9dee-c0693f6ef844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iotaSOFT Insertion System
• Version Model Number: IM-03
• Company DUNS: 080053045
• Company Name: Iotamotion, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00850002960037 [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: false

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