FDA.reportPublic FDA data

iotaSOFT Insertion System

Primary DI
00850002960051
Brand
iotaSOFT Insertion System
Company
Iotamotion, Inc.
Model
IM-01
Device description
iotaSOFT Control Console
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QQHPowered Insertion System For A Cochlear Implant Electrode Array

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQHPowered Insertion System For A Cochlear Implant Electrode ArrayEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190055000iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc.2021-10-01QQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002960051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002960051008500029600518500029600510850002960051

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical system application softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080053045
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002960006iotaSOFT Insertion SystemIM-002024-09-20
00850002960020iotaSOFT Insertion SystemIM-022024-09-20
00850002960037iotaSOFT Insertion SystemIM-032024-09-20
00850002960044iotaSOFT Insertion SystemIM-042024-09-20
00850002960068iotaSOFT Insertion SystemIM-052024-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850002960006iotaSOFT Insertion SystemIotamotion, Inc.QQH2024-09-20
00850002960020iotaSOFT Insertion SystemIotamotion, Inc.QQH2024-09-20
00850002960037iotaSOFT Insertion SystemIotamotion, Inc.QQH2024-09-20
00850002960044iotaSOFT Insertion SystemIotamotion, Inc.QQH2024-09-20
00850002960068iotaSOFT Insertion SystemIotamotion, Inc.QQH2024-09-20