| Primary Device ID | 00634916001068 |
| NIH Device Record Key | e4002c1c-d9cf-4343-88e6-33dc880d0cc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stanguard Drape |
| Version Model Number | 22625022 |
| Catalog Number | 22625022 |
| 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 | 00634916001068 [Primary] |
| GS1 | 10634916001065 [Unit of Use] |
| GS1 | 10634916001068 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
Moist Heat or Steam Sterilization
[00634916001068]
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 |
| 00634916343199 | Barrier Supreme Universal Drape, StanGuard FEN 4"RND - SM, 20X20 BARRIER SUPREME JADE |
| 00634916343151 | SM UNIV DRAPE StanGuard 20X20 - B S W/3-1/2" FEN (SR 11657) |
| 00634916343144 | SM DRAPE SHEET Stanguard - 60X45 ST SUPREME 1 PLY |
| 00634916119831 | StanGuard Barrier Supreme Universal Fenestrated Drape 20X20 - RM (98 7833) USE: 22626022 SMALL |
| 00634916115567 | Barrier Supreme Universal Drape, StanGuard, SM 27X60 - 1PLY MISTY (SR 15138) |
| 00634916001099 | TABLE COVER StanGuard 58X79 - BARRIER SUPREME (SR 11910) |
| 00634916001082 | SM UNIV DRAPE StanGuard - 20X20 BARRIER SUPREME |
| 00634916001075 | Barrier Supreme Universal Drape, StanGuard, SM 20X20 |
| 00634916001068 | LAP DRAPE StanGuard - 70X120 Barrier/Standard Supreme |
| 00634916001044 | MAYO COVER StanGuard - 22 X 52.25 Barrier/Standard Supreme Sugical Drape |
| 00634916001006 | Standard Supreme 1-ply Drape Sheet MED 45X90 StanGuard |