TrakStar Patient Data Management System Software 83-00060-000

GUDID 00850005944126

Cloud version of TrakStar Patient Data Management System Software

NEURONETICS, INC.

Magnetic neural stimulation system

• Primary Device ID: 00850005944126
• NIH Device Record Key: 7c5575c2-debf-446d-9048-8c6ebcd8f66d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrakStar Patient Data Management System Software
• Version Model Number: Version 7.5 (Cloud)
• Catalog Number: 83-00060-000
• 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
• Phone: 877-600-7555
• Email: customersupport@neurostar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944126 [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: 2023-03-02
• Device Publish Date: 2023-02-22

On-Brand Devices [TrakStar Patient Data Management System Software]

• 00850005944515: Combined local/cloud version of TrakStar Patient Data Management System Software
• 00850005944133: Cloud version of TrakStar Patient Data Management System Software
• 00850005944126: Cloud version of TrakStar Patient Data Management System Software
• 00850005944102: Local version of TrakStar Patient Data Management System Software
• 00850005944096: Local version of TrakStar Patient Data Management System Software
• 00850005944553: Cloud version of TrakStar Patient Data Management System Software
• 00850005944447: Local version of TrakStar Patient Data Management System Software