| Primary Device ID | 01634916801155 |
| NIH Device Record Key | bf926ea9-0929-430c-9d1c-2a24e957dfa8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Generic Polyester Isolation Gown |
| Version Model Number | 661Y4974 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 48 |
| 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 | 00634916801156 [Primary] |
| GS1 | 01634916801155 [Unit of Use] |
| OEA | Non-Surgical Isolation Gown |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
[01634916801155]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-21 |
| Device Publish Date | 2021-06-11 |
| 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 |