FDA UDI
In Commercial Distribution
🇺🇸 United States
CloudTMS Edge
DI: 04650075337783
·
Model: Main unit
·
NEUROSOFT, OOO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CloudTMS Edge
- Primary DI
- 04650075337783
- Version / Model
- Main unit
- Company Name
- NEUROSOFT, OOO
- Labeler DUNS
- 643212926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- a5c2af9e-3d43-4b19-820a-67d09aae76f9
Device Description
The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
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 | 04650075337783 | GS1 |
Customer Contacts
- Phone
- 617 8403263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250689 | 000 |