| Primary Device ID | 08050705890354 |
| NIH Device Record Key | 0e560536-c9cb-4301-b70d-8192b822e6c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLED15-F |
| Version Model Number | SOLED15-F /SC2 |
| Catalog Number | 110406 |
| 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 |