| Primary Device ID | 00634916297799 |
| NIH Device Record Key | 4317934e-1d9b-40ad-b37f-fb3189ea0e47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNDERPAD QUILTED DERMATHERAPY |
| Version Model Number | 59751800 |
| Catalog Number | 59751800 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 24 |
| 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 | |
| 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 | 00634916297799 [Primary] |
| GS1 | 10634916297796 [Unit of Use] |
| GS1 | 10634916297799 [Unit of Use] |
| FMW | Cover, Mattress (Medical Purposes) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-29 |
| 00634916341928 | UNDERPAD DERMATHERAPY QLTD 34X36 WHITE W/WRAPPEL BARRIER SR16170 |
| 00634916297799 | UNDERPAD DERMATHERAPY QUILTED 34X45 WHITE W/WRAPPEL BARR SR17716 |
| 00634916265613 | UNDERPAD DERMATHERAPY QUILTED 38X50 WHITE W/WRAPPEL BARRIER |
| 00634916142549 | UNDERPAD DERMATHERAPY QLTD 34X36 50P/50N W/80P/20R SOAKER WHITE |