| Primary Device ID | 00634916354812 |
| NIH Device Record Key | c3e3419e-373c-4abb-9b48-7ecb0b2cd722 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrier Supreme Drape |
| Version Model Number | 96601662 |
| Catalog Number | 96601662 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 100 |
| 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 | 00634916354812 [Primary] |
| GS1 | 10634916354819 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
[00634916354812]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-13 |
| Device Publish Date | 2020-04-03 |
| 00634916059861 | DRAPE BARRIER SUPREME/T180 CEIL 30X30 - 5X.75 RECT FEN (SR 13154) |
| 00634916059748 | DRAPE BARRER SUPREME/T180 CEIL 24X30 - 3.50X.75 RECT FEN (SR 13146) |
| 00634916059618 | DRAPE BARRIER SUPREME/T180 CEIL 24X30 - 5X.75 RECT FEN (SR 13147) |
| 00634916059601 | DRAPE BARR SUP/T180 CEIL 30X36 - 9X.75 RECT FEN (SR 13144) |
| 00634916059595 | DRAPE BARRIER SUPREME/T180 CEIL 22X22 - 2" RND FEN (SR 13190) |
| 00634916054958 | CIRCUMCISION DRAPE BARR SUP CEIL 20X21.5 - 3/4" RND FEN (S/R 12628) |
| 00634916354812 | Barrier Supreme Circumcision Drape, 1-Ply Barrier Supreme, 3x3 Reinforcement Pad, 1" Fenestratio |