| Primary Device ID | 10634916779094 |
| NIH Device Record Key | 350844f9-3006-4bf3-a35d-b44d98b2db7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isolation Gown, Reusable |
| Version Model Number | 666405F5 |
| Catalog Number | 666405F5 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 60 |
| 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 | false |
| 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 |