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NeuroStar TMS Therapy System

FDA UDI

Class II (US FDA UDI)

by Neuronetics Inc.

Identity

Trade Name
NeuroStar TMS Therapy System FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Model / Reference
Upgrade Kit 3.0 US FDA UDI

Identifiers

Catalog Number
81-35000-000 FDA UDI
Primary DI / UDI-DI
00869378000155 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
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
MRI Safety
MR Safe FDA UDI

Category: Magnetic neural stimulation system

NeuroStar TMS Therapy System by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic neural stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neuronetics Inc.

Sources (1)

  • FDA UDI 4e9781e5-4115-464b-bbbf-fb760d86d7f5 34 fields · synced Jun 1, 2026