Wonderful Dental

GUDID 00850006606078

Mint Fluoride Varnish 0.4 mL Unidose 100 packs

Roses and Rubies, LLC

Dental cavity varnish
Primary Device ID00850006606078
NIH Device Record Key64a1e781-82f5-476f-84f0-74a5ab84d588
Commercial Distribution StatusIn Commercial Distribution
Brand NameWonderful Dental
Version Model NumberFL01011100
Company DUNS114844746
Company NameRoses and Rubies, LLC
Device Count100
DM Exemptfalse
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 Numbertrue
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

Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co
Phone1-866-920-4561
Emaildavid@wonderfuldental.co

Device Identifiers

Device Issuing AgencyDevice ID
GS100850006606023 [Primary]
GS100850006606078 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

On-Brand Devices [Wonderful Dental]

00850006606092Bubblegum Fluoride Varnish 0.4mL cups 100 pack
00850006606009Marshmallow Fluoride Varnish 0.4 mL cups 100 pack
00850006606122Strawberry Fluoride Varnish 0.4mL cups 100 pack
00850006606115Mint Fluoride Varnish 0.4mL cups 100 pack
00850006606146Strawberry Fluoride Varnish 0.4mL Unidose 100 pack
00850006606108Chocolate Fluoride Varnish 0.4mL cups 100 pack
00850006606139Bubblegum Fluoride Varnish 0.4mL Unidose 100 pack
00850006606085Marshmallow Fluoride Varnish 0.4 mL Unidose 100 pack
00850006606078Mint Fluoride Varnish 0.4 mL Unidose 100 packs
00850006606061Chocolate Fluoride Varnish 0.4 mL Unidose 100 pack
00850006606504S'mores Fluoride Varnish 0.4mL cups 100 pack
00850006606467Mint Fluoride Varnish 0.4mL cups 100 pack
00850006606429Chocolate Fluoride Varnish 0.4mL cups 100 pack
00850006606382Marshmallow Fluoride Varnish 0.4 mL cups 100 pack
00850006606344Strawberry Fluoride Varnish 0.4mL cups 100 pack
00850006606306Bubblegum Fluoride Varnish 0.4mL cups 100 pack
00850006606498S'mores Fluoride Varnish 0.4mL Unidose 100 pack

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