| Primary Device ID | 15056860000072 |
| NIH Device Record Key | 551c28fa-9154-4d98-9e83-7b1478b58c66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentell Hydrogel Sheet Dressing |
| Version Model Number | GEN-11470 |
| Company DUNS | 170967876 |
| Company Name | Gentell, LLC |
| Device Count | 5 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |