| Primary Device ID | 00634916059519 |
| NIH Device Record Key | 17aeb1b1-d445-4d36-804c-8d7fe043699b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OR TOWEL ABS |
| Version Model Number | 48541123 |
| Catalog Number | 48541123 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 144 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916059519 [Primary] |
| GS1 | 10634916059519 [Unit of Use] |
| FRL | Fiber, Medical, Absorbent |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916059519]
Moist Heat or Steam Sterilization
[00634916059519]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-29 |
| 00634916296969 | OR TOWEL ABS KAUM 18X31 CEIL IMP RM (98 8296) USE: 48541124 |
| 00634916059519 | OR TOWEL ABS 18X30 JADE IMP HMD 3 OR 4 SIDES |
| 00634916059502 | OR TOWEL ABS 18X30 MISTY IMP HMD 3 OR 4 SIDES |
| 00634916059496 | OR TOWEL ABS 18X30 CEIL IMP HMD 3 OR 4 SIDES |
| 00634916043136 | OR TOWEL ABS 18X33 KAUM MISTY RM (98 7042) USE: 48502322 |
| 00634916040005 | OR TOWEL ABS 18X32 JADE KAUM RM (98 7045) USE: 48810423 |
| 00634916013559 | OR TOWEL ABS 18X33 JADE KAUM RM (98 6268) USE: 48502323 |