DentaPure 60 Day Independednt Water Bottle Cartridge

GUDID 10732224005529

Independent Water Bottle Cartridge

CROSSTEX INTERNATIONAL, INC.

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Primary Device ID10732224005529
NIH Device Record Keya3fb76e1-86fa-4beb-b272-7c418c1da1eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDentaPure 60 Day Independednt Water Bottle Cartridge
Version Model NumberDP40B
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone1-585-359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110732224005529 [Unit of Use]
GS150732224005527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, operative dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-29
Device Publish Date2022-11-21

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