| Primary Device ID | 10634916819479 | 
| NIH Device Record Key | 1f057db2-f708-4195-b8e0-b11ef463b486 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Surgical Towel | 
| Version Model Number | 48541323 | 
| 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 | |
| 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 | 00634916819472 [Primary] | 
| GS1 | 10634916819479 [Unit of Use] | 
| FRL | Fiber, Medical, Absorbent | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
[10634916819479]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-12-22 | 
| Device Publish Date | 2021-12-10 | 
| 10634916392545 - Mammogram Jacket | 2024-12-30 Mammogram Jacket, KAUMO, Nova Pink, OSFA, Front Closure w/2 Metal Snaps; Use stock product 74F69081 | 
| 00634916707038 - Pediatric Lap Drape | 2023-10-18 Pediatric Lap Drape, 1 Ply WrapPel Ripstop Body, 29x34 Reinforcement Bound Pad (1 Ply Zorwick II, 1 Ply ComPel), 6" Triangular B | 
| 00634916788358 - ComPel OR Gown | 2023-10-18 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Nec | 
| 00634916795493 - ProMax Surgical Gown | 2023-10-18 ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With | 
| 00634916857535 - ComPel Isolation Gown | 2023-10-18 Isolation Gown, ComPel, Yellow, Raglan Sleeves, Metal Snaps at Neck and Waist, Elastic Sleeve Opening and Thumb Loop | 
| 00634916790528 - Isolation Gown EasyRelease | 2023-08-22 Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, XL, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves | 
| 10634916508960 - DermaTherapy Fitted Sheet | 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10 | 
| 10634916578710 - DermaTherapy Fitted Sheet | 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around with Blue Thread, 35x84x11 |