| Primary Device ID | 08806195981320 |
| NIH Device Record Key | 0a716232-296b-4b44-bdaa-aab6a9bd44cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UF(II) Implant System |
| Version Model Number | SSCS 3430S |
| Catalog Number | SSCS 3430S |
| Company DUNS | 631085206 |
| Company Name | DIO Corporation |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |