| Primary Device ID | 00634916318548 |
| NIH Device Record Key | 74ad8d52-4630-4378-a36f-a57a4906f575 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrier Supreme Surgical Drape Sheet |
| Version Model Number | 95681635 |
| Catalog Number | 95681635 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916318548 [Primary] |
| GS1 | 10634916318545 [Unit of Use] |
| GS1 | 10634916318548 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
[00634916318548]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-02 |
| Device Publish Date | 2018-01-29 |
| 00634916318548 | CIRCUMCISION SHEET 25X26 BLUE - 1PLY BARRIER SUPREME (SR 17993) |
| 00634916047929 | Barrier Supreme Spinal Sheet, MISTY - 22X23.5 1PLY (S/R 12384) |