Treatment Pack, 50 Pack

GUDID 00850005944232

Treatment Pack to be used with the SenStar Connect Treatment Link

NEURONETICS, INC.

Magnetic neural stimulation system

• Primary Device ID: 00850005944232
• NIH Device Record Key: 08087c91-77c0-4e83-a8d5-dc7262c50a93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treatment Pack, 50 Pack
• Version Model Number: 81-00930-000
• Company DUNS: 134960348
• Company Name: NEURONETICS, INC.
• Device Count: 50
• 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: true
• Lot Batch: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944232 [Unit of Use]
GS1	10850005944239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161519

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: 2022-10-13
• Device Publish Date: 2022-10-05

Devices Manufactured by NEURONETICS, INC.

• 00850005944829 - NeuroStar Advanced Therapy System: 2025-05-16 NeuroStar Advanced Therapy System, recertified
• 00850005944836 - NeuroStar Advanced Therapy System: 2025-05-16 NeuroStar Advanced Therapy System, recertified
• 00850005944812 - NeuroStar Advanced Therapy System: 2025-05-15 NeuroStar Advanced Therapy System, recertified
• 10850005944635 - SenStar Treatment Link: 2024-08-12
• 00850005944652 - SenStar Connect Treatment Link: 2024-08-12
• 00850005944041 - Arm Support Cushion, Gray: 2024-02-12 Arm Cushion to be used with the NeuroStar Advanced Therapy System
• 00850005944164 - Wedge Cushion, Gray: 2024-02-12 Wedge Cushion to be used with the NeuroStar Advanced Therapy System
• 00850005944171 - Head Cushion Insert Set, Gray: 2024-02-12 Head Cushion Insert Set to be used with the NeuroStar Advanced Therapy System