Primary Device ID | 50732224004988 |
NIH Device Record Key | 2ba9a435-7c1a-4277-ba6e-cae8a2f45759 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Safe-Flo Plus Saliva Ejector |
Version Model Number | M1003CLWH |
Catalog Number | M1003CLWH |
Company DUNS | 057728685 |
Company Name | CROSSTEX INTERNATIONAL, INC. |
Device Count | 100 |
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 | false |
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)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00732224005003 [Unit of Use] |
GS1 | 10732224005000 [Primary] |
GS1 | 50732224004988 [Package] Contains: 10732224005000 Package: Case [20 Units] In Commercial Distribution |
DYN | Mouthpiece, saliva ejector |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-02 |
Device Publish Date | 2024-11-22 |
50732224005022 | White/Pink, Bubblegum Scented |
50732224005015 | White/Green, Mint Scented |
50732224004988 | Clear/White |
50732224005008 | White/White |