| Primary Device ID | 05430000459020 |
| NIH Device Record Key | 4b9fba8d-2e47-4bac-bdf5-d3d0b7968df4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spirotome |
| Version Model Number | SS0806 |
| Company DUNS | 370588912 |
| Company Name | Medinvents NV |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |