ImpressaChrome 861-130

GUDID 00190746008115

SUPPLIES-IMPRESSA/CHROME ALGINATE 453 G/1 LB BAG

AMERICAN ORTHODONTICS CORPORATION

Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material
Primary Device ID00190746008115
NIH Device Record Keyaef0e7ac-d478-492c-8f56-9c7686c6f6a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpressaChrome
Version Model Number861-130
Catalog Number861-130
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
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(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746008115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-08

On-Brand Devices [ImpressaChrome]

00190746008122SUPPLIES-IMPRESSA/CHROME ALGINATE STARTER KIT
00190746008115SUPPLIES-IMPRESSA/CHROME ALGINATE 453 G/1 LB BAG

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