| Primary Device ID | 00634916343267 |
| NIH Device Record Key | 4e1fcd75-0301-4b73-a4fd-a8ae83bab7f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Promax Surgical Gown |
| Version Model Number | 75670474 |
| Catalog Number | 75670474 |
| 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 | 00634916343267 [Primary] |
| GS1 | 10634916343267 [Unit of Use] |
| FYA | Gown, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
Moist Heat or Steam Sterilization
[00634916343267]
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 |
| 00634916343267 | OR GWN PROMAX AQUA XL |
| 00634916343243 | OR GWN PROMAX KNIT AQUA 3XL - MLR FRONT SNPS @ NK/TT WST |
| 10634916819042 | ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co |
| 10634916819035 | ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co |
| 10634916819028 | ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co |
| 10634916825388 | Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size |
| 10634916825371 | Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size |
| 10634916825364 | Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size |
| 00634916795493 | ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, T |