| Primary Device ID | 05060534510968 |
| NIH Device Record Key | 7b0997c8-5390-473d-bc11-1b38935351b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMOOTHSKIN DuoLux LED Facemask |
| Version Model Number | TN2010 |
| Company DUNS | 223616320 |
| Company Name | I-SMART DEVELOPMENTS LIMITED |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060534510968 [Primary] |
| OHS | Light Based Over The Counter Wrinkle Reduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-30 |
| Device Publish Date | 2024-08-22 |
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