| Primary Device ID | 00634916000634 |
| NIH Device Record Key | fc3a521c-c83c-49fc-a77b-3066b728ea29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Supreme Wrapper (hemmed) |
| Version Model Number | 21526012 |
| Catalog Number | 21526012 |
| Company DUNS | 006999858 |
| Company Name | STANDARD TEXTILE CO., INC. |
| Device Count | 60 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634916000634 [Primary] |
| GS1 | 10634916000634 [Unit of Use] |
| FRG | Wrap, Sterilization |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00634916000634]
Moist Heat or Steam Sterilization
[00634916000634]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-01-29 |
| 00634916343229 | WRAPPER T-180 JADE 54X72 2PLY - HEMMED W/SALMON THRD (SR13191) |
| 00634916343212 | WRAPPER T-180 JADE 35X35 2PLY - HEMMED W/BLUE THREAD |
| 00634916343205 | WRAPPER T-180 JADE 12X12 2PLY - HEMMED W/BLUE THREAD |
| 00634916343090 | WRAPPER T-180 JADE 24X24 2PLY - HEMMED W/GREEN THREAD |
| 00634916343083 | WRAPPER T-180 JADE 18X18 2PLY - HEMMED W/LAVENDER THREAD |
| 00634916343076 | WRAPPER T-180 MTY 35X35 2PLY - HEMMED W/BLUE THREAD |
| 00634916343069 | WRAPPER T-180 MTY 12X12 2PLY - HEMMED W/BLUE THREAD |
| 00634916146301 | WRAPPER T180 2PLY 26X72 MISTY - CONCEALED HEMS (SR 15580) |
| 00634916010466 | WRAPPER T-180 MTY 54X72 2PLY - HEMMED W/CORAL THREAD |
| 00634916010381 | WRAPPER T-180 MTY 30X30 2PLY - HEMMED/LT PINK |
| 00634916000733 | WRAPPER T-180 JADE 54X54 2PLY - HEMMED W/GREY THREAD |
| 00634916000719 | WRAPPER T-180 JADE 45X45 2PLY - HEMMED W/WHITE THREAD |
| 00634916000634 | WRAPPER T-180 MTY 54X54 2PLY - HEMMED W/GREY THREAD |