| Primary Device ID | B303E0100 |
| NIH Device Record Key | 10d84b7b-88c0-43c8-9811-87606817f2c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versatech 600 2.0 |
| Version Model Number | V600 2.0 |
| 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 |