| Primary Device ID | 00634916014921 |
| NIH Device Record Key | 6828d09f-34c9-4c5d-a1dc-d47d6c865328 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrier Supreme Surgical Drape |
| Version Model Number | 95689202 |
| Catalog Number | 95689202 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 12 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916014921 [Primary] |
| GS1 | 10634916014921 [Unit of Use] |
| GS1 | 10634916014928 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
Moist Heat or Steam Sterilization
[00634916014921]
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 |
| 00634916327731 | DRP UNIV HEART 24X24 MISTY - 1PLY BARRIER SUPREME 7.75"FEN SR18816B |
| 00634916225389 | DRAPE SURGICAL 15.5x15.5 CEIL - 2PLY Barrier Supreme 6X5 FEN SR16837 |
| 00634916197440 | CIRCUMCISION DRAPE 14X15 MISTY - 2PLY Barrier Supreme W/1"FEN SR16685 |
| 00634916190564 | EYE DRAPE 26X36.5 MISTY - 3"FEN Standard/Barrier Supreme (SR 16571) |
| 00634916187038 | DRAPE SM UNIV Barrier Supreme JADE 25.5x19 - W/9X11 REINF FEN (S/R 16419) |
| 00634916183016 | LAP Drape Barrier Supreme CEIL 84X69 - WINGED 1PLY 5X20 FEN (SR16384) |
| 00634916171396 | Small Universal Fenestrated Drape, 1-Ply Barrier Supreme, KAUM 20X20 - RM (98 8155) USE: 2262602 |
| 00634916147018 | LEGGING Barrier Supreme 15.25X35.5 - 1PLY (SR 16132) MISTY |
| 00634916127355 | DRAPE LAP Barrier Supreme CEIL 98X120 - W/5X17 OVAL FEN (SR 15512) |
| 00634916098099 | DRAPE LAP BARRIER SUPREME CEIL 83.5X108.25 - W/5X17 OVAL FEN |
| 00634916087895 | DRAPE TOP HEART Barrier Supreme CEIL - 73X85.5 W/U-FEN (SR 14271) |
| 00634916087888 | DRP BTTM HEART Barrier Supreme CEIL - 73X83 W/U-FEN (SR 14272) |
| 00634916043105 | MAYO COVER T180/BS 24X48 MISTY - 1PLY (S/R 11942) |
| 00634916043099 | CIRCUMCISION SHEET 25X25 JADE - 1PLY T180/BARRIER SUPREME (S/R 11943) |
| 00634916043082 | DRP CYSTO T180/Barrier Supreme JADE 66X56 - 4.5 RND FEN (S/R 11944) |
| 00634916042023 | WINDOW DRAPE BARRIER SUPREME JADE - 26X20 W/FEN (S/R 11908) |
| 00634916033083 | SM UNIV DRAPE CEIL 20X20 - BARRIER SUPREME (S/R 11536) |
| 00634916031263 | DRAPE CORONARY BPASS CBL 106X120 - T180 Barrier Supreme 12X50 FEN (SR 11405 |
| 00634916016888 | Drape Sheet Barrier Supreme MTY 45X90 - (S/R 10053) PRO# 788.0 |
| 00634916014921 | DRAPE ENDO/CYSTO Barrier Supreme 45X75 - 4.5 RND FEN SR9753 PRO# 770.0 |
| 00634916008272 | TREATMENT DRAPE SPECIAL - 45X45 1 PLY Barrier Supreme BLUE |
| 00634916008258 | Drape Sheet Barrier Supreme 44x85 - 1PLY QCM/MRKM LABEL (SR 11827) |
| 00634916005431 | CIRCUMCISION DRAPES SPECIAL - 22X22 1PLY BARRIER SUPREME |
| 00634916708578 | Barrier Supreme Surgical Drape, 1 -Ply T180 Base, 1 Ply 6 3/4" x 7" Barrier Supreme Reinforcemen |