| Primary Device ID | 50732224000928 |
| NIH Device Record Key | c4e4478f-d86f-426d-b558-f2da728c5479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crosstex Disposable Face Shields |
| Version Model Number | GCSS |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 24 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0167 |
| regulatoryaffairs@hu-friedy.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224000923 [Unit of Use] |
| GS1 | 10732224000920 [Primary] |
| GS1 | 50732224000928 [Package] Contains: 10732224000920 Package: [12 Units] In Commercial Distribution |
| FYE | DRESS, SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
| 00732224000930 | Face Shield, 3/4 Length Clear (7"), Bulk Pack |
| 50732224000942 | Face Shield, Full Length (9") Clear |
| 50732224000928 | Face Shield, 3/4 Length Clear (7") |