| Primary Device ID | 00634916394528 |
| NIH Device Record Key | 8e05f408-4cb8-4886-ae4a-69f35cccce4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAMMOGRAPHY GOWN |
| Version Model Number | 74296089 |
| Catalog Number | 74296089 |
| 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 |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com | |
| Phone | 1-800-999-0400 |
| GUDID@standardtextile.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916394528 [Primary] |
| GS1 | 10634916394528 [Unit of Use] |
| FME | Gown, Examination |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-21 |
| Device Publish Date | 2018-05-21 |
| 00634916457667 | Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, singl |
| 00634916457643 | Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, singl |
| 00634916394535 | MAMMOGRAPHY GOWN, 100% Polyester, Burgundy 3XL |
| 00634916394528 | MAMMOGRAPHY GOWN, 100% Polyester, Burgundy OSFA |