| Primary Device ID | 00372380000384 |
| NIH Device Record Key | c7ee4b2e-a99b-4720-9905-bfe3fd82e4da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivera Pharmaceuticals, Inc |
| Version Model Number | Silinoin |
| Company DUNS | 081244342 |
| Company Name | VIVERA PHARMACEUTICALS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 10372380000008 - szosil medical grade silicone sheeting gel for scars | 2024-02-16 |
| 00372380000384 - Vivera Pharmaceuticals, Inc | 2022-07-11A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. |
| 00372380000384 - Vivera Pharmaceuticals, Inc | 2022-07-11 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th |
| 00372380000315 - Vivera Pharmaceuticals | 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th |
| 00372380000322 - Vivera Pharmaceuticals | 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th |
| 00372380000018 - szosil medical grade silicone gel sheeting for scar | 2019-09-30 |
| 00372380000025 - szosil silicone stick | 2019-09-30 |
| 00372380000032 - szosil skin repair serum | 2019-09-30 |