| Primary Device ID | 08050705890279 |
| NIH Device Record Key | 68e98997-ca4d-4fff-a5ee-24f775d12b1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLED15 |
| Version Model Number | SOLED15 /T |
| Catalog Number | 110303 |
| Company DUNS | 435188508 |
| Company Name | ACEM SPA |
| 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 | true |
| OTC Over-The-Counter | false |