| Primary Device ID | 07540191000463 |
| NIH Device Record Key | 9eb7dcf8-1fe0-4380-a4ed-9ba18d201fc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GSR2 B.F. System |
| Version Model Number | T2001M |
| Company DUNS | 209284132 |
| Company Name | Technologie de Pensée Ltée |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540191000463 [Primary] |
| HCC | Device, Biofeedback |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-20 |
| Device Publish Date | 2017-08-31 |
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| 07540191000586 - MyOnyx Mobile App | 2023-06-15 |
| 07540191000593 - MyOnyx | 2023-06-15 |
| 07540191000623 - eVu Senz App iOS | 2022-05-16 |
| 07540191000609 - Pressure Sensor | 2022-03-31 |
| 07540191000616 - Vaginal Pressure Probe | 2022-03-31 |
| 07540191000555 - MyOnyx | 2020-07-24 |
| 07540191000562 - NEUROINFINITI 2 | 2020-07-24 |