NeuroStar Headrest

GUDID 00850005944348

The NeuroStar Headrest can be adjusted to the patient's comfort.

NEURONETICS, INC.

Magnetic neural stimulation system
Primary Device ID00850005944348
NIH Device Record Key34f5a2a2-bb36-48d2-bb7d-ee166cf6444c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroStar Headrest
Version Model Number81-72026-000
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005944348 [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 Date2024-01-11
Device Publish Date2024-01-03

Devices Manufactured by NEURONETICS, INC.

00850005944829 - NeuroStar Advanced Therapy System2025-05-16 NeuroStar Advanced Therapy System, recertified
00850005944836 - NeuroStar Advanced Therapy System2025-05-16 NeuroStar Advanced Therapy System, recertified
00850005944812 - NeuroStar Advanced Therapy System2025-05-15 NeuroStar Advanced Therapy System, recertified
10850005944635 - SenStar Treatment Link2024-08-12
00850005944652 - SenStar Connect Treatment Link2024-08-12
00850005944041 - Arm Support Cushion, Gray2024-02-12 Arm Cushion to be used with the NeuroStar Advanced Therapy System
00850005944164 - Wedge Cushion, Gray2024-02-12 Wedge Cushion to be used with the NeuroStar Advanced Therapy System
00850005944171 - Head Cushion Insert Set, Gray2024-02-12 Head Cushion Insert Set to be used with the NeuroStar Advanced Therapy System
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