FDA UDI
In Commercial Distribution
🇺🇸 United States
iotaSOFT Insertion System
DI: 00850002960006
·
Model: IM-00
·
Iotamotion, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iotaSOFT Insertion System
- Primary DI
- 00850002960006
- Version / Model
- IM-00
- 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
- 98dab9f4-49ac-4513-af97-4d39fb2548df
Device Description
iotaSOFT 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 | 00850002960006 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN190055 | 000 |