| 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 |
| Phone | 877-600-7555 |
| customersupport@neurostar.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005944379 [Primary] |
| GS1 | 10850005944376 [Package] Contains: 00850005944379 Package: Case [10 Units] In Commercial Distribution |
| OBP | Transcranial Magnetic Stimulator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
| 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. |