| Primary Device ID | 00634916018141 |
| NIH Device Record Key | 380a1088-ce47-4c23-9c39-555914eeee64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Supreme Drape |
| Version Model Number | 95560542 |
| Catalog Number | 95560542 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 36 |
| 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 | 00634916018141 [Primary] |
| GS1 | 10634916018141 [Unit of Use] |
| GS1 | 10634916018148 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
Moist Heat or Steam Sterilization
[00634916018141]
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 |
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| 00634916322552 | HEART POCKET T180 12X15.5 MSTY - 1PLY STANDARD SUPREME W/TABS (SR18824) |
| 00634916256970 | SHT OPEN HEART 25X66 MISTY - 2PLY STD SUPREME (SR 17334) |
| 00634916091052 | SPINAL DRAPE SHEET STANDARD SUPREME MISTY 28X32 - 2PLY STD SUP W/3X3 BND FEN |
| 00634916045383 | SPINAL DRAPE SHEET 29X29 JADE SPECIAL - 29X29 1 PLY STD SUP (SR 12196) |
| 00634916018141 | ARM SHEETS STANDARD SUPREME 31X60 MISTY - 31X60 2PLY |
| 00634916018134 | Standard Supreme RECTANG LEGGING T-180 JADE - 12X36 T-180 SINGLE PLY |
| 00634916012422 | DRAPE EYE 30X30 JADE - 2PLY STANDARD SUPREMEW/FEN PRO#723.0 |
| 00634916010374 | GOITER SHEET MISTY 72X90 - 1 PLY STD SUPREME HEMMED |
| 00634916007770 | EYE DRAPE 18X18 MISTY - 1PLY STANDARD SUPREME W/REIN (S/R 12161) |
| 00634916005363 | SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO |
| 00634916005356 | PERI SHEET STD SUPREME 49X70 - 1PLY STD S W/REIN-CO |
| 00634916000016 | Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Poc |