| Primary Device ID | 08059173391851 |
| NIH Device Record Key | edb8f5a6-005e-4c78-8b3d-fb8a9274c1f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twain Evo |
| Version Model Number | OAM001834.01 |
| Company DUNS | 436045833 |
| Company Name | QUANTA SYSTEM SPA |
| Device Count | 1 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |