| Primary Device ID | B75800RDA445 |
| NIH Device Record Key | 8f37cb3a-f199-465c-8fc7-b6159d5bc317 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dorsaVi - V6 Overwrap Adhesives |
| Version Model Number | V6 Overwrap Adhesives |
| Catalog Number | RS-A483 |
| Company DUNS | 757139956 |
| Company Name | DORSAVI LTD |
| Device Count | 50 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com | |
| Phone | +611800367728 |
| support@dorsavi.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B758000RDA483 [Primary] |
| HIBCC | B75800RDA445 [Unit of Use] |
| HCC | Device, Biofeedback |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2023-08-30 |
| B75800RDA445 - dorsaVi - V6 Overwrap Adhesives | 2023-09-07Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors. |
| B75800RDA445 - dorsaVi - V6 Overwrap Adhesives | 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors. |
| B75800RDA865 - dorsaVi - V6 EMG DAP | 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 EMG Sensors. |
| B75800RDA866 - dorsaVi - V6 Low Back AMI DAP | 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors. |
| B758000VMPLU0 - ViMove+ | 2023-09-07 ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumba |
| B758000035630 - 30 Minute Disposable Application Pad | 2023-08-30 Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits. |
| B7580000PS100 - Professional Suite | 2023-08-30 Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower b |
| B7580000VMV50 - Movement Suite / V5 Sensor Kit | 2023-08-30 Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back |
| B758000RDA482 - dorsaVi | 2023-08-30 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors. |