MEDICOM DURAFLOR 10011-US

GUDID 20686864022460

DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -TUBE

AMD Medicom Inc

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Primary Device ID20686864022460
NIH Device Record Key564dda7a-b9e6-4e50-b85a-d1ced4210d92
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDICOM DURAFLOR
Version Model Number10011-US
Catalog Number10011-US
Company DUNS256880576
Company NameAMD Medicom Inc
Device Count1
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca
Phone+1(514)636-6262
Emailamdudi@medicom.ca

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110686864022463 [Primary]
GS120686864022460 [Package]
Contains: 10686864022463
Package: OUTER CASE [12 Units]
In Commercial Distribution

FDA Product Code

LBHVARNISH, CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-19
Device Publish Date2016-09-11

On-Brand Devices [MEDICOM DURAFLOR]

20686864041034DURAFLOR VARNISH 5% FLUORIDE SAMPLE PACK
20686864020961DURAFLOR VARNISH 5% FLUORIDE RASPBERRY -DOSE
20686864020954DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -DOSE
20686864022460DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -TUBE
20686864020930DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -DOSE
20686864020947DURAFLOR VARNISH 5% FLUORIDE RASPBERRY -DOSE

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