| Primary Device ID | 10372380000008 |
| NIH Device Record Key | 80709615-f469-458e-8030-2891c491b5a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | szosil medical grade silicone sheeting gel for scars |
| Version Model Number | 1 |
| Company DUNS | 081244342 |
| Company Name | VIVERA PHARMACEUTICALS, INC. |
| Device Count | 2 |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00372380000001 [Unit of Use] |
| GS1 | 10372380000008 [Primary] |
| MDA | Elastomer, Silicone, For Scar Management |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2019-08-23 |
| 10372380000008 - szosil medical grade silicone sheeting gel for scars | 2024-02-16 |
| 10372380000008 - szosil medical grade silicone sheeting gel for scars | 2024-02-16 |
| 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 |