| Primary Device ID | 05056387438900 |
| NIH Device Record Key | 6139182c-88ab-4ace-9755-21c8718e113a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | In-Situ Repositioning Sheet Medium |
| Version Model Number | M921539-M |
| Company DUNS | 423632996 |
| Company Name | SILVALEA LIMITED |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |