| Primary Device ID | 00634916785906 |
| NIH Device Record Key | 930412ed-1139-4a04-aa85-1ce6e3252f45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Generic Polyester Isolation Gown |
| Version Model Number | 666406F4 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| 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 | 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 |
| 01634916801155 | EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at Neck/W |
| 00634916785913 | Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl |
| 00634916785906 | Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl |
| 00634916785890 | Isolation Gown - Reusable, AAMI Level 1, Tie Closures Neck and Waist, Set-In Sleeves, Elastic Sl |