MEDICOM DURAFLOR ULTRA 1016-CH30

GUDID 10686864056505

DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE

AMD Medicom Inc

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Primary Device ID10686864056505
NIH Device Record Key78ab2007-5d50-4c76-aa10-44e0fdd5105b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDICOM DURAFLOR ULTRA
Version Model Number1016-CH30
Catalog Number1016-CH30
Company DUNS256880576
Company NameAMD Medicom Inc
Device Count30
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
Emaildabecassis@amdritmed.com
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100686864056508 [Unit of Use]
GS110686864056505 [Primary]
GS120686864056502 [Package]
Package: PACK [6 Units]
In Commercial Distribution

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 Date2020-01-16
Device Publish Date2020-01-08

On-Brand Devices [MEDICOM DURAFLOR ULTRA]

20686864041027DURAFLOR ULTRA VARNISH 5% FLUORIDE SAMPLE PACK -DOSE
20686864041010DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
20686864041003DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
20686864040990DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
20686864040983DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
20686864040976DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
20686864040969DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
10686864056536DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
20686864056526DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
10686864056512DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
10686864056505DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
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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