| Primary Device ID | 16974795050148 |
| NIH Device Record Key | 94e4b886-a589-430e-a21b-d088dec962f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | Non-Sterile |
| Company DUNS | 724981491 |
| Company Name | Henan Maidingkang Medical Technology Co., Ltd. |
| 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974795050141 [Primary] |
| GS1 | 16974795050148 [Package] Contains: 06974795050141 Package: [10 Units] In Commercial Distribution |
| PFP | Silicone Hydrogel For Scar Management |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-03 |
| 06974795053142 - MEDLOT | 2025-10-07 |
| 06974795055474 - MEDLOT | 2025-10-07 |
| 06974795056341 - MEDLOT | 2025-09-01 |
| 06974795057256 - MEDLOT | 2025-09-01 |
| 06974795058314 - MEDLOT | 2025-09-01 |
| 06974795051940 - MEDLOT | 2025-08-21 |
| 06974795055580 - MEDLOT | 2025-08-21 |
| 06974795059861 - MEDLOT | 2025-08-21 |