Eagle No Drift 001-943X

GUDID 00190746007668

EAGLE NO DRIFT ADHESIVE CARPULE-TRANSPARENT 20/PKG

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device ID00190746007668
NIH Device Record Key3aa540cd-e4d0-48b9-992c-b032285842b7
Commercial Distribution Discontinuation2019-07-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEagle No Drift
Version Model Number001-943X
Catalog Number001-943X
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 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Light

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746007668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-25
Device Publish Date2016-11-09

On-Brand Devices [Eagle No Drift]

00190746134098EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG
00190746134081EAGLE NO DRIFT ADHESIVE CARPULE KIT
00190746007743EAGLE NO DRIFT MODIFIED SEALANT 6 GMS
00190746007682EAGLE NO DRIFT ADHESIVE CARPULE KIT W/ FLUORSURE SEALANT
00190746007668EAGLE NO DRIFT ADHESIVE CARPULE-TRANSPARENT 20/PKG
00190746007651EAGLE NO DRIFT ADHESIVE CARPULE 20/PKG
00190746000027EAGLE NO DRIFT ADHESIVE CARPULE KIT
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