| Primary Device ID | 10634916819523 | 
| NIH Device Record Key | c1cf2d9d-af1e-4d8a-9f92-e95646ea52c6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | X-Ray Gown | 
| Version Model Number | 74512489 | 
| 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 | |
| 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 | 00634916819526 [Primary] | 
| GS1 | 10634916819523 [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 | 2021-12-22 | 
| Device Publish Date | 2021-12-10 | 
| 00634916103618 | X-RAY GOWN IMAGE FIRST BURGUNDY LARGE | 
| 10634916819523 | X-Ray Gown, 100% spun poly, Burgundy, Size Large, Front Opening |