D-Tect MT Accessory

GUDID 00850005944539

D-Tect MT Accessory is an accessory to the NeuroStar Advanced Therapy System intended to aid in the motor threshold (MT) determination process

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

• Primary Device ID: 00850005944539
• NIH Device Record Key: 43f9ae79-eb63-4216-bc8a-93b7da29d93e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Tect MT Accessory
• Version Model Number: 81-00241-000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222230

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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by NEURONETICS, INC.

• 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
• 00850005944188 - Arm Support Cushion, Blue: 2024-02-12 Arm Cushion to be used with the NeuroStar Advanced Therapy System
• 00850005944416 - Wedge Cushion, Blue: 2024-02-12 Wedge Cushion to be used with the NeuroStar Advanced Therapy System
• 00850005944492 - Head Cushion Insert Set, Blue: 2024-02-12 Head Cushion Insert Set to be used with the NeuroStar Advanced Therapy System
• 10850005944307 - NeuroSITE: 2024-01-11 The NeuroSITE is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and
• 00850005944348 - NeuroStar Headrest: 2024-01-11 The NeuroStar Headrest can be adjusted to the patient's comfort.