NeuroStar Advanced Therapy System 81-37000-000

GUDID 00850005944577

2.X to 3.7 System Upgrade Kit

NEURONETICS, INC.

Magnetic neural stimulation system
Primary Device ID00850005944577
NIH Device Record Keyacbf82b5-2e38-443e-b355-b1633aec8d56
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroStar Advanced Therapy System
Version Model Number2.X to 3.7 System Upgrade Kit
Catalog Number81-37000-000
Company DUNS134960348
Company NameNEURONETICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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@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
GS100850005944577 [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 Date2022-10-10
Device Publish Date2022-09-30

On-Brand Devices [NeuroStar Advanced Therapy System]

008500059445913.X to 3.7 System Upgrade Kit for NeuroStar systems that are TouchStar Capable
008500059445843.X to 3.7 System Upgrade Kit for NeuroStar systems that are not TouchStar Capable
008500059445772.X to 3.7 System Upgrade Kit
00850005944522NeuroStar Mobile Console Version 3.7, 120V
00850005944430NeuroStar Mobile Console, recertified
00850005944423NeuroStar Mobile Console, recertified
00850005944621NeuroStar Mobile Console 3.8, 120V, US

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