NeuroStar Advanced Therapy System 81-04315-000

GUDID 00850005944522

NeuroStar Mobile Console Version 3.7, 120V

NEURONETICS, INC.

Magnetic neural stimulation system

• Primary Device ID: 00850005944522
• NIH Device Record Key: 09d88bb5-6a1f-4b59-80ff-40eb15b91ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroStar Advanced Therapy System
• Version Model Number: Version 3.7
• Catalog Number: 81-04315-000
• 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
• Phone: 877-600-7555
• Email: customersupport@neurostar.com
• Phone: 877-600-7555
• Email: customersupport@neurostar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201158

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: 2022-10-10
• Device Publish Date: 2022-09-30

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