| Primary Device ID | B303D0000 |
| NIH Device Record Key | 227f9722-7957-4458-abe8-48b8621af26d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versatech 1100 |
| Version Model Number | V1100 |
| Company DUNS | 245707815 |
| Company Name | Usine Rotec Inc |
| 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 | 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 | false |
| OTC Over-The-Counter | false |