FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroStar System Software
DI: 00850005944355
·
Model: Version 3.8
·
NEURONETICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroStar System Software
- Primary DI
- 00850005944355
- Version / Model
- Version 3.8
- Catalog Number
- 83-00093-000
- Company Name
- NEURONETICS, INC.
- Labeler DUNS
- 134960348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-03
- Public Version
- 1
- Public Version Date
- 2024-01-11
- Public Version Status
- New
- Public Device Record Key
- f59c9209-379d-486f-baa4-606e2109002d
Device Description
System Software for NeuroStar Mobile Console
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | Neurology | 882.5805 | 2 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | Neurology | 882.5802 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61124 | Magnetic neural stimulation system | An assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005944355 | GS1 |
Customer Contacts
- Phone
- 877-600-7555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233621 | 000 |