OCD MT Cap

GUDID 10850005944680

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

NEURONETICS, INC.

Magnetic neural stimulation system

• Primary Device ID: 10850005944680
• NIH Device Record Key: b3b08341-d7c4-4b74-a142-b062ba4cf436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCD MT Cap
• Version Model Number: 85-00397-000
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005944683 [Primary]
GS1	10850005944680 [Package]; Contains: 00850005944683; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231350

FDA Product Code

• QCI: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

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: 2023-08-24
• Device Publish Date: 2023-08-16

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• 00850005944652 - SenStar Connect Treatment Link: 2024-08-12
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• 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