MT Cap

GUDID 10850005944376

The MT Cap is used to aid in the motor threshold (MT) determination process.

NEURONETICS, INC.

Magnetic neural stimulation system

• Primary Device ID: 10850005944376
• NIH Device Record Key: ae204c98-9e93-40c8-b420-ead13af140df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MT Cap
• Version Model Number: 85-01353-000
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-600-7555
• Email: customersupport@neurostar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944379 [Primary]
GS1	10850005944376 [Package]; Contains: 00850005944379; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213543

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

Devices Manufactured by NEURONETICS, INC.

• 00850005944935 - NeuroStar Headrest: 2025-12-23 The NeuroStar Headrest can be adjusted to the patient's comfort. NeuroStar Headrest Assembly Domestic, Recertified
• 00850005944881 - NeuroStar Head Support System, Domestic: 2025-12-17 The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and
• 00850005944898 - NeuroStar Head Support System, Domestic: 2025-12-17 The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and
• 00850005944911 - NeuroStar Headrest: 2025-12-17 The NeuroStar Headrest can be adjusted to the patient's comfort. NeuroStar Headrest Assembly Domestic, Demo.
• 00850005944928 - D-Tect MT Accessory: 2025-12-17 D-Tect MT Accessory is an accessory to the NeuroStar Advanced Therapy System intended to aid in the motor threshold (MT) determi
• 00850005944843 - NeuroStar Advanced Therapy System: 2025-12-10 NeuroStar Advanced Therapy System, Demo
• 00850005944850 - NeuroStar Advanced Therapy System: 2025-12-10 NeuroStar Advanced Therapy System, Demo
• 00850005944867 - NeuroStar Advanced Therapy System: 2025-12-10 NeuroStar Advanced Therapy System, Demo