| Primary Device ID | 00714196390905 |
| NIH Device Record Key | 30e2ebf8-625a-4b20-9fe5-e041ba70d015 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComfortFoam Border Heel |
| Version Model Number | 43580 |
| Company DUNS | 883925562 |
| Company Name | DERMARITE INDUSTRIES LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |