NeuroStar TMS Therapy System 81-01315-000

GUDID 00869378000100

.

NEURONETICS, INC.

Magnetic neural stimulation system, mobile Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system
Primary Device ID00869378000100
NIH Device Record Keyec89aec3-80cc-4fe7-af2b-397dc938785b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroStar TMS Therapy System
Version Model NumberNeuroStar 2.0 US
Catalog Number81-01315-000
Company DUNS134960348
Company NameNEURONETICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neuronetics.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100869378000100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBPTranscranial Magnetic Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [NeuroStar TMS Therapy System]

00869378000155Upgrade Kit 3.0 US
00869378000148Multi-Coil Option Upgrade
00869378000117NeuroStar 3.0 US
00869378000100.

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