| Primary Device ID | 00634916042528 |
| NIH Device Record Key | eb0c5040-4fce-4786-a868-72369367e603 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Promax OR Gowns |
| Version Model Number | 7565P085 |
| Catalog Number | 7565P085 |
| 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 | 00634916042528 [Primary] |
| GS1 | 10634916042528 [Unit of Use] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
Moist Heat or Steam Sterilization
[00634916042528]
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 |
| 00634916295122 | OR GWN PROMAX KAUM AQUA XL - RM (98 8282) USE: 7567P314 |
| 00634916295115 | OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313 |
| 00634916294972 | OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313 |
| 00634916189575 | OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST (SR 16518) |
| 00634916147643 | OR GWN PROMAX KNIT AQUA XL - SHORT MS @ NK TT WST BARCODE |
| 00634916147612 | OR GWN PROMAX KAUM AQUA XL - RM (98-8282) MEMORIAL HERMANN |
| 00634916147599 | OR GWN PROMAX KAUM AQUA 3XL - RM (98-8282) MEMORIAL HERMANN |
| 00634916146622 | OR GWN PROMAX KNIT AQUA 3XL - SNPS @ NK/TT WST W/BARCODE |
| 00634916141870 | OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST W/BARCODE |
| 00634916141863 | OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/TT WST W/BARCODE |
| 00634916141801 | OR GWN PROMAX KAUM AQUA 2XL - RM (98 6749) USE: 7567P313 |
| 00634916141795 | OR GWN PROMAX KAUM AQUA XL - RM (98 6749) USE: 7567P314 |
| 00634916139310 | OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS TTIES @ WST |
| 00634916139303 | OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS TTIES @ WST |
| 00634916139297 | OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS (SR 15936) |
| 00634916086683 | OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS @ NK/TT WST |
| 00634916086676 | OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS @ NK/TT WST |
| 00634916086669 | OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS @ NK/TT WST |
| 00634916081428 | OR GWN XLN PROMAX KNIT AQUA 2X - SNPS @ NK/TT WST (SR 13868) |
| 00634916042528 | OR GWN PROMAX KNIT AQUA L - SNPS @ NK/WST (S/R 12087) |
| 00634916042511 | OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/WST |