| Primary Device ID | 06972949026080 |
| NIH Device Record Key | aee7483f-71b7-44ed-8374-e157353c343d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R&L Medical |
| Version Model Number | J-15cm×12cm×2pcs |
| Company DUNS | 415588794 |
| Company Name | Hangzhou R&L Medical Device 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 | false |
| Lot Batch | false |
| 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 | 06972949026080 [Package] Contains: 86972949026086 Package: [2 Units] In Commercial Distribution |
| GS1 | 16972949026087 [Package] Package: [48 Units] In Commercial Distribution |
| GS1 | 86972949026086 [Primary] |
| 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 | 2025-04-30 |
| Device Publish Date | 2025-04-22 |
| 06972949026080 | J-15cm×12cm×2pcs |
| 06972949026073 | J-15cm×12cm |
| 06972949026066 | J-12cm×6cm×2pcs |
| 06972949026059 | J-12cm×6cm |
| 06972949026042 | J-12cm×3cm×2pcs |
| 06972949026035 | J-12cm×3cm |