NeuroStar Advanced Therapy System 81-01315-00R

GUDID 00850005944423

NeuroStar Mobile Console, recertified

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

• Primary Device ID: 00850005944423
• NIH Device Record Key: 26892066-2410-4d47-b2c1-372b35e8b06f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroStar Advanced Therapy System
• Version Model Number: 2.X
• Catalog Number: 81-01315-00R
• Company DUNS: 134960348
• Company Name: NEURONETICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160703

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: 2023-04-03
• Device Publish Date: 2023-03-25

On-Brand Devices [NeuroStar Advanced Therapy System]

• 00850005944591: 3.X to 3.7 System Upgrade Kit for NeuroStar systems that are TouchStar Capable
• 00850005944584: 3.X to 3.7 System Upgrade Kit for NeuroStar systems that are not TouchStar Capable
• 00850005944577: 2.X to 3.7 System Upgrade Kit
• 00850005944522: NeuroStar Mobile Console Version 3.7, 120V
• 00850005944430: NeuroStar Mobile Console, recertified
• 00850005944423: NeuroStar Mobile Console, recertified
• 00850005944621: NeuroStar Mobile Console 3.8, 120V, US