Primary Device ID | 50732224000942 |
NIH Device Record Key | 7b889bde-ed6b-49f0-ba8a-b0092792f0a7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Crosstex Disposable Face Shields |
Version Model Number | GCSS9 |
Company DUNS | 057728685 |
Company Name | CROSSTEX INTERNATIONAL, INC. |
Device Count | 18 |
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 | 00732224000947 [Unit of Use] |
GS1 | 10732224000944 [Primary] |
GS1 | 50732224000942 [Package] Contains: 10732224000944 Package: [6 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") |