| Primary Device ID | 00634916041934 |
| NIH Device Record Key | 5c3cf9a8-569d-45c7-b53a-4a9be0d8a55c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perval Surgical Gown |
| Version Model Number | 75665135 |
| Catalog Number | 75665135 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00634916041934 [Primary] |
| GS1 | 10634916041934 [Unit of Use] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
[00634916041934]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2018-01-29 |
| 00634916053616 | OR GWN PERVAL PLUS CEIL XL - TT @ WST W/BCODE S/R 12657 |
| 00634916049176 | OR GWN PERVAL PLUS CEIL 3XL - TT @ WST W/BCODE S/R 12374 |
| 00634916041941 | OR GWN PERVAL PLUS CEIL XL - TT @ WST W/BCODE S/R 11874 |
| 00634916041934 | OR GWN PERVAL PLUS CEIL L - TT @ WST W/BCODE S/R 11874 |