NeuroSITE
GUDID 10850005944307
The NeuroSITE is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes.
NEURONETICS, INC.
Magnetic neural stimulation system| Primary Device ID | 10850005944307 |
| NIH Device Record Key | e34a04d0-ebae-427e-8393-1f1cb209557f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroSITE |
| Version Model Number | 81-72024-000 |
| 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 | 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 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com | |
| Phone | 877-600-7555 |
| customersupport@neurostar.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005944300 [Primary] |
| GS1 | 10850005944307 [Package] Contains: 00850005944300 Package: Inner Pack [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233621
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 | 2024-01-11 |
| Device Publish Date | 2024-01-03 |
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 |
Trademark Results [NeuroSITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROSITE 98167219 not registered Live/Pending |
Neuronetics, Inc. 2023-09-06 |
 NEUROSITE 75092362 2170051 Dead/Cancelled |
Thomson Holdings Inc. 1996-04-22 |
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