Sparkle Prophylaxis Paste

GUDID 10732224001989

Prophylaxis Paste with Xylitol, Bubble Gum,Medium Grit

CROSSTEX INTERNATIONAL, INC.

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Primary Device ID10732224001989
NIH Device Record Keyc5df7e65-061d-48c8-a6f2-d0db61ca4731
Commercial Distribution StatusIn Commercial Distribution
Brand NameSparkle Prophylaxis Paste
Version Model NumberUPMBG
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count200
DM Exempttrue
Pre-market Exempttrue
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)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
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
GS100732224001982 [Unit of Use]
GS110732224001989 [Primary]
GS150732224001987 [Package]
Package: case [12 Units]
In Commercial Distribution

FDA Product Code

EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-04-15
Device Publish Date2022-11-15

On-Brand Devices [Sparkle Prophylaxis Paste]

00732224001906Prophylaxis Paste with Xylitol, Mint, Coarse Grit
50732224002113Prophylaxis Paste with Xylitol, White Chocolate,Medium Grit
50732224002106Prophylaxis Paste with Xylitol, Spearmint,Medium Grit
50732224002090Prophylaxis Paste with Xylitol, Fruity,Medium Grit
50732224002083Prophylaxis Paste with Xylitol, Cinnamon,Medium Grit
50732224002076Prophylaxis Paste with Xylitol, White Chocolate,Coarse Grit
50732224002069Prophylaxis Paste with Xylitol, Spearmint,Coarse Grit
50732224002052Prophylaxis Paste with Xylitol, Fruity,Coarse Grit
50732224002045Prophylaxis Paste with Xylitol, Cinnamon,Coarse Grit
50732224002021Prophylaxis Paste with Xylitol, Assorted flavors, Medium Grit
50732224002014Prophylaxis Paste with Xylitol, Orange Vanilla,Medium Grit
50732224002007Prophylaxis Paste with Xylitol, Mint,Medium Grit
50732224001994Prophylaxis Paste with Xylitol, Cherry,Medium Grit
50732224002038Prophylaxis Paste with Xylitol, Bubble Gum,Medium Grit
50732224001970Prophylaxis Paste with Xylitol, Berrylicious, Medium Grit
50732224001963Prophylaxis Paste with Xylitol, Assorted flavors, Coarse Grit
50732224001956Prophylaxis Paste with Xylitol, Orange Vanilla, Coarse Grit
50732224001949Prophylaxis Paste with Xylitol, Mint, Coarse Grit
50732224001932Prophylaxis Paste with Xylitol, Cherry, Coarse Grit
50732224001925Prophylaxis Paste with Xylitol, Berrylicious Assorted, Rasberry, Blueberry, Strawberry, Coarse G
50732224001918Prophylaxis Paste with Xylitol, Berrylicious Assorted, Rasberry, Blueberry, Strawberry, Coarse G
10732224001989Prophylaxis Paste with Xylitol, Bubble Gum,Medium Grit

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