| Primary Device ID | 05708265011186 |
| NIH Device Record Key | 46caac41-f338-42ad-9c96-4c0d26487d18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA OperaScope™ Tubing & Drape kit |
| Version Model Number | OP-TDK-6 |
| Catalog Number | OP-TDK-6 |
| Company DUNS | 305088619 |
| Company Name | Lina Medical ApS |
| 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 | 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 | true |
| OTC Over-The-Counter | false |