Head Cushion Insert Set, Blue

GUDID 00850005944492

Head Cushion Insert Set to be used with the NeuroStar Advanced Therapy System

NEURONETICS, INC.

Magnetic neural stimulation system
Primary Device ID00850005944492
NIH Device Record Key8d8e01c9-c6cb-4320-ba77-2da33d4cccdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameHead Cushion Insert Set, Blue
Version Model Number87-00657-000
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 Batchtrue
Serial Numberfalse
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
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
GS100850005944492 [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 Date2024-02-12
Device Publish Date2024-02-02

Devices Manufactured by NEURONETICS, INC.

00850005944881 - NeuroStar Head Support System, Domestic2025-12-17 The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and
00850005944898 - NeuroStar Head Support System, Domestic2025-12-17 The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and
00850005944911 - NeuroStar Headrest2025-12-17 The NeuroStar Headrest can be adjusted to the patient's comfort. NeuroStar Headrest Assembly Domestic, Demo.
00850005944928 - D-Tect MT Accessory2025-12-17 D-Tect MT Accessory is an accessory to the NeuroStar Advanced Therapy System intended to aid in the motor threshold (MT) determi
00850005944843 - NeuroStar Advanced Therapy System2025-12-10 NeuroStar Advanced Therapy System, Demo
00850005944850 - NeuroStar Advanced Therapy System2025-12-10 NeuroStar Advanced Therapy System, Demo
00850005944867 - NeuroStar Advanced Therapy System2025-12-10 NeuroStar Advanced Therapy System, Demo
00850005944874 - NeuroStar Advanced Therapy System2025-12-10 NeuroStar Advanced Therapy System, Demo

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