| Primary Device ID | 04711182608156 |
| NIH Device Record Key | 495f9404-5b43-4d22-8d18-05d566b4a539 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rystora Silicone Scar Gel |
| Version Model Number | SGA01501 |
| Company DUNS | 656763489 |
| Company Name | FORTUNE MEDICAL INSTRUMENT CORP. |
| Device Count | 24 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |