| Primary Device ID | 10634916779285 |
| NIH Device Record Key | efbea97d-7e19-4f5d-8767-b17cb4da82c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isolation Gown, Reusable |
| Version Model Number | 666405F2 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916779288 [Primary] |
| GS1 | 10634916779285 [Unit of Use] |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 10634916779285 | Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves with White Cuffs, Size 3XL |
| 10634916779261 | Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves with White Cuffs, XL |
| 10634916779094 | Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves with White Cuffs, Size Larg |