| Primary Device ID | 00634916232141 |
| NIH Device Record Key | fa20df84-f74c-4912-8373-f4678694d484 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fenestrated Surgical Drape |
| Version Model Number | 96801224 |
| Catalog Number | 96801224 |
| 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 | 00634916232141 [Primary] |
| GS1 | 10634916232141 [Unit of Use] |
| GS1 | 10634916232148 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
Moist Heat or Steam Sterilization
[00634916232141]
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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| 00634916307825 | DRAPE MULTI PURPOSE 13X17 JADE - T180 ATCHD PAD 5"FEN (SR17814) |
| 00634916247039 | DRAPE SURGICAL MISTY 18X18 - 2PLY T-180 W/FEN (S/R 17103) |
| 00634916232387 | DRAPE T180 25X25 CEIL BLUE - W/5" SQUARE FEN (S/R 16988) |
| 00634916232141 | DRAPE CIRCUMCISION 17X13 CEIL - W/1" ROUND FEN (S/R 16900) |
| 00634916186925 | DRAPE CIRCUMCISION 18X24 BLEA - 1PLY T180 W/FEN (SR 14998) |
| 00634916028218 | DRAPE CIRCUMCISION CEIL 17X17 - W/3/4" RND FEN (S/R 11101) |