| Primary Device ID | 00634916080964 |
| NIH Device Record Key | c3191520-af9b-4811-9361-6eaa34f2e1ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Supreme Surgical Drape |
| Version Model Number | 95500412 |
| Catalog Number | 95500412 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 72 |
| 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 | 00634916080964 [Primary] |
| GS1 | 10634916080961 [Unit of Use] |
| GS1 | 10634916080964 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
Moist Heat or Steam Sterilization
[00634916080964]
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 |
| 00634916322569 | CIRCUMCISION DRAPE 22X22 MISTY - 2PLY Standard Supreme 2.5"FEN (SR18823) |
| 00634916309812 | CIRCUMCISION DRAPE 12X12 JADE - 2PLY 3/4"FEN SR17847 |
| 00634916263268 | BOOT LEGGING STANDARD SUPREME KAUM CEIL - RM (98 7802) USE: 95512534 |
| 00634916247084 | CIRCUMCISION DRAPE 23X23 MISTY - 1PLY Standard Supreme 1"FEN (SR17188) |
| 00634916243185 | DRAPE UNIVERSAL JADE 22X22 - 2PLY Standard Supreme W/1"FEN S/R 14826 |
| 00634916230529 | DRAPE SPINAL CEIL 20X20 - 1PLY Standard Supreme 4"RND FEN SR16990 |
| 00634916230512 | Standard Supreme Spinal Surgical Drape SPINAL CEIL 33X33 - 1PLY 3"RND FEN SR16989 |
| 00634916191271 | CIRCUMCISION DRAPE 14.5X18 MTY - 1PLY Standard Supreme 1-3/8"FEN SR16585 |
| 00634916190779 | DRAPE SURGICAL 14X25 MISTY - 1PLY Standard Supreme W/3"FEN (SR16584) |
| 00634916128727 | LEG WRAP Standard Supreme Surgical Drape T180 MISTY 6X112.75 - 2PLY HEMMED ALL SIDES SR15563 |
| 00634916105896 | DRAPE PED CHEST LAP CEIL - 79X94.5X54 STANDARD SUPREME (S/R 14884) |
| 00634916102918 | DRAPE SHEET Standard Supreme MISTY - 70x106 2PLY |
| 00634916080964 | DRAPE SURG MISTY 20.75X20.75 - 2PLY STANDARD SUPREME (SR 13813) |
| 00634916080216 | DRAPE BUNNY CEIL 14.5X31.5 - 2PLY STANDARD SUPREME (SR 13835) |
| 00634916064858 | DRAPE SUTURE Standard Supreme CEIL 22X22 - W/3" RND FEN (SR 12966) |
| 00634916064841 | DRAPE SUTURE Standard Supreme CEIL 22X22 - W/2" RND FEN (SR 12965) |
| 00634916063608 | DRAPE SUTURE Standard Supreme CEIL 22X22 - W/1" RND FEN (SR 12964) |
| 00634916058147 | T-DRAPE STANDARD SUPREME JADE 12X12 - 4"SLIT W/1-1/2" FEN (SR 13078) |
| 00634916029116 | DRAPE UNIVERSAL JADE 21X21.5 - 1PLY STANDARD SUPREME (S/R 11266) |
| 00634916026696 | DRAPE CIRCUMCISION MISTY 12X12 - STANDARD SUPREME W/3/4" FEN (S/R 11062) |
| 00634916023718 | DRAPE ANIMAL RESEARCH 48X72 MSTY - HEMMED ON 3 SIDES Standard Supreme (SR 10686) |
| 00634916023688 | DRAPE DERM 1PLY 20X20 CEIL BL - W/1 PLY & 4"FENESTRATED CTRD(SR 10688) |
| 00634916009378 | CIRCUMCISION DRAPE SPECIAL - 27X27 1PLY ST SUPREME MISTY |
| 00634916005967 | SURGICAL DRAPE SPEC MISTY CUT - 18X36 1PLY Standard Supreme W/REIN/FEN |
| 00634916005394 | BOOT LEGGING CEIL - 1PLY STANDARD SUPREME (SR 15224) |