| Primary Device ID | EBCI0216US0 |
| NIH Device Record Key | 7cbef0cf-65da-4a47-bcad-7267fbe393b0 |
| Commercial Distribution Discontinuation | 2019-04-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | g.USBamp |
| Version Model Number | USB Biosignal Amplifier |
| Catalog Number | 0216US |
| Company DUNS | 300916041 |
| Company Name | g.tec medical engineering GmbH |
| 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 | true |
| Manufacturing Date | false |
| 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 | +437251222400 |
| support@gtec.at |
| Device Size Text, specify | 0 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBCI02160 [Previous] |
| HIBCC | EBCI0216US0 [Primary] |
| GWL | Amplifier, Physiological Signal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-21 |
| Device Publish Date | 2017-11-23 |
| EBCI0216US0 | The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain |
| EBCI02160 | The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain |