| Primary Device ID | 00634916352641 |
| NIH Device Record Key | 22f287fb-995c-4f02-91ff-dc0c2eb2e7b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrier Supreme Eye Drape |
| Version Model Number | 96801654 |
| Catalog Number | 96801654 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 48 |
| 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 | 00634916352641 [Primary] |
| GS1 | 10634916352648 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
Moist Heat or Steam Sterilization
[00634916352641]
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 |
| 00634916019353 - Standard Supreme | 2026-03-19 Instrument Drape, 2 Ply Standard Supreme, 5% COTTON, 45% POLYESTER |
| 00634916099225 - INSTRUMENT COVER | 2026-03-19 Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester |
| 00634916120905 - Instrument Holder | 2026-03-19 Wrappel Instrument Holder with Pockets, 100% Polyester |
| 00634916349740 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER. |
| 00634916781373 - WrapPel Table Cover | 2026-03-19 WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER' |
| 00634916788105 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER. |
| 00634916788112 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER. |
| 00634916788129 - Compel MLR OR Gown | 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER |