MEDICOM DURAFLOR ULTRA 1016-M200

GUDID 20686864040990

DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE

AMD Medicom Inc

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Primary Device ID20686864040990
NIH Device Record Keybd12a673-ab04-4ec5-93c7-77f2d5697b64
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDICOM DURAFLOR ULTRA
Version Model Number1016-M200
Catalog Number1016-M200
Company DUNS256880576
Company NameAMD Medicom Inc
Device Count200
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 Latextrue
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
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca
Phone+1(514)636-6262
Emailmkansou@medicom.ca

Device Dimensions

Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100686864040996 [Unit of Use]
GS120686864040990 [Primary]

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 Date2020-01-09
Device Publish Date2016-09-15

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20686864040983DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
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10686864056536DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
20686864056526DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
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20686864056717DURAFLOR ULTRA VARNISH 5% FLUORIDE Sample Pack - 1 unit dose each (Bubble Gum & Cherry)
20686864055901DURAFLOR ULTRA VARNISH 5% FLUORIDE ASSORTED FLAVORS - 400 units (MINT - 00686864040996 - 200 un

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