| Primary Device ID | 00816140020095 |
| NIH Device Record Key | fc569834-cb8f-4cd7-9018-952af0352b2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sTMS mini |
| Version Model Number | DWG-0505 |
| Catalog Number | DWG-0505 |
| Company DUNS | 013665656 |
| Company Name | ENEURA, INC., |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Phone | +1(408)245-6400 |
| Customercare@eneura.com | |
| Phone | +1(408)245-6400 |
| Customercare@eneura.com | |
| Phone | +1(408)245-6400 |
| Customercare@eneura.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816140020095 [Primary] |
| OKP | Transcranial magnetic stimulator for the treatment of migraine headache |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-01 |
| 00816140020125 | Transcranial Magnetic Stimulator Device |
| 00816140020118 | Transcranial Magnetic Stimulator Device |
| 00816140020095 | Transcranial Magnetic Stimulator AC Adapter |
| 00816140020088 | Transcranial Magnetic Stimulator Device |
| 00816140020071 | Transcranial Magnetic Stimulator Device |