MEDICOM DURAFLOR ULTRA 1016-BG200

GUDID 10686864056536

DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE

AMD Medicom Inc

Dental coating, tooth-desensitizing

Primary Device ID	10686864056536
NIH Device Record Key	d2a4823f-6176-435d-999f-e9b89cd244d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	MEDICOM DURAFLOR ULTRA
Version Model Number	1016-BG200
Catalog Number	1016-BG200
Company DUNS	256880576
Company Name	AMD Medicom Inc
Device Count	200
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(514)636-6262
Email	amdudi@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca
Phone	+1(514)636-6262
Email	mkansou@medicom.ca

Device Dimensions

Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter
Total Volume	0.4 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864056539 [Unit of Use]
GS1	10686864056536 [Primary]

FDA Product Code

LBH	VARNISH, CAVITY

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-01-16
Device Publish Date	2020-01-08

On-Brand Devices [MEDICOM DURAFLOR ULTRA]

20686864041027	DURAFLOR ULTRA VARNISH 5% FLUORIDE SAMPLE PACK -DOSE
20686864041010	DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
20686864041003	DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
20686864040990	DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
20686864040983	DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
20686864040976	DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
20686864040969	DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
10686864056536	DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
20686864056526	DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
10686864056512	DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
10686864056505	DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
20686864056717	DURAFLOR ULTRA VARNISH 5% FLUORIDE Sample Pack - 1 unit dose each (Bubble Gum & Cherry)
20686864055901	DURAFLOR ULTRA VARNISH 5% FLUORIDE ASSORTED FLAVORS - 400 units (MINT - 00686864040996 - 200 un