| Primary Device ID | 00802357234400 |
| NIH Device Record Key | 80332097-887e-4e5a-b111-51c2e4649e7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EPIGEL W/STAYS, UNIVERSAL |
| Version Model Number | 223440 |
| Company DUNS | 003173028 |
| Company Name | MEDICAL SPECIALTIES INCORPORATED |
| 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 | true |
| Serial Number | false |
| 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 | false |