NeuroStar System Software 83-00054-000

GUDID 00850005944089

System Software for NeuroStar Mobile Console

NEURONETICS, INC.

Magnetic neural stimulation system
Primary Device ID00850005944089
NIH Device Record Key0d6de071-ac7a-42bf-a7ae-37b218100b4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroStar System Software
Version Model NumberVersion 3.5
Catalog Number83-00054-000
Company DUNS134960348
Company NameNEURONETICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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@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
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com
Phone877-600-7555
Emailcustomersupport@neurostar.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005944089 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-01
Device Publish Date2023-02-21

On-Brand Devices [NeuroStar System Software]

00850005944508System Software for NeuroStar Mobile Console
00850005944119System Software for NeuroStar Mobile Console
00850005944089System Software for NeuroStar Mobile Console
00850005944355System Software for NeuroStar Mobile Console

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