NeuroStar System Software 83-00093-000

GUDID 00850005944355

System Software for NeuroStar Mobile Console

NEURONETICS, INC.

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 ID: 00850005944355
• NIH Device Record Key: f59c9209-379d-486f-baa4-606e2109002d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroStar System Software
• Version Model Number: Version 3.8
• Catalog Number: 83-00093-000
• Company DUNS: 134960348
• Company Name: NEURONETICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233621

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [NeuroStar System Software]

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