Identity
- Trade Name
- NeuroStar TMS Therapy System FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Model / Reference
- Multi-Coil Option Upgrade FDA UDI
Identifiers
- Catalog Number
- 81-30000-000 FDA UDI
- Primary DI / UDI-DI
- 00869378000148 FDA UDI
- 510(k) Number
- DEN070003 FDA UDI
- FDA Product Code
- OBP FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5805 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
NeuroStar TMS Therapy System by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
DEN070003 also covers:
- Arm Support Cushion, Blue — Neuronetics Inc.
- Arm Support Cushion, Gray — Neuronetics Inc.
- Head Cushion Insert Set, Blue — Neuronetics Inc.
- Head Cushion Insert Set, Gray — Neuronetics Inc.
- Head Side Pad, 3 Pack — Neuronetics Inc.
- NeuroStar TMS Therapy System — Neuronetics Inc.
- SenStar Treatment Link — Neuronetics Inc.
- SenStar Treatment Link — Neuronetics Inc.
- Wedge Cushion, Blue — Neuronetics Inc.
- Wedge Cushion, Gray — Neuronetics Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neuronetics Inc.
Sources (1)
- FDA UDI 9bb1d1c3-78a6-4352-b66e-ff9cf07fdabc 36 fields · synced May 30, 2026