| Primary Device ID | 05056387439525 |
| NIH Device Record Key | b530d935-5884-48e8-9316-8ba4e2df04bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | In-Situ Deluxe Superfine Double Layer Small |
| Version Model Number | M921536-S |
| 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 | 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 | false |
| OTC Over-The-Counter | false |