iotaSOFT Insertion System

Basic Information

• Brand Name: iotaSOFT Insertion System
• Primary DI: 00850002960068
• Version / Model: IM-05
• Company Name: Iotamotion, Inc.
• Labeler DUNS: 080053045
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-20
• Public Version: 1
• Public Version Date: 2024-09-30
• Public Version Status: New
• Public Device Record Key: 612eeabf-6c85-4cef-89df-cef98d4e86a8

Device Description

iotaSOFT Plus Drive Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QQH	Powered Insertion System For A Cochlear Implant Electrode Array	Ear, Nose, Throat	874.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43265	Robotic 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002960068	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN190055	000