| Primary Device ID | 00841439102794 |
| NIH Device Record Key | af272b87-fd4d-4f28-9242-24f8c7c6407f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Proutra™ |
| Version Model Number | MT6XCALS |
| Catalog Number | MT6XCALS |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, 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 | 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 |
| Phone | +1(712)737-8688 |
| radiotherapy.complaints@civcort.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439102794 [Primary] |
| JAI | Couch, radiation therapy, powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-06-17 |
| Device Publish Date | 2017-08-02 |
| 00841439111703 | Proutra™ Robotic Couch System Version 1.7.4 |
| 00841439111376 | Proutra™ Robotic Couch System Version 1.7.3 |
| 00841439102794 | Replacement calibration fixture |
| 00841439102787 | Reconditioned, for use with Elekta Precise bases |
| 00841439102770 | For use with Elekta Precise bases |
| 00841439102763 | Reconditioned, for use with Varian Exact™ bases |
| 00841439102756 | For use with Varian Exact™ bases |
| 00841439102749 | Reconditioned, for use with Siemens TXT bases |
| 00841439102732 | For use with Siemens TXT bases |