NT3 857-AMDL-1818W

GUDID 00190746165870

WIRE NITI FORM A MD LOWER 018X018 IND 10/PK

AMERICAN ORTHODONTICS CORPORATION

Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire
Primary Device ID00190746165870
NIH Device Record Keyd3901e0a-49f7-42de-83b6-5d4403bf2b1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNT3
Version Model Number857-AMDL-1818W
Catalog Number857-AMDL-1818W
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 Datefalse
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
Phone+1(800)558-7687
Emailinfo@americanortho.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 and 38 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746165870 [Primary]

FDA Product Code

DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [NT3]

00190746076718WIRE NITI VLP UNIV 021X025 IND 10/PK
00190746076701WIRE NITI VLP UNIV 021X025 10/PK
00190746076695WIRE NITI VLP UNIV 020 IND 10/PK
00190746076688WIRE NITI VLP UNIV 020 10/PK
00190746076671WIRE NITI VLP UNIV 016X022 IND 10/PK
00190746076664WIRE NITI VLP UNIV 016X022 10/PK
00190746076657WIRE NITI VLP UNIV 016X016 IND 10/PK
00190746076640WIRE NITI VLP UNIV 016X016 10/PK
00190746076633WIRE NITI FORM I LOWER 021X025 T=20 28MM IND 10/PK
00190746076626WIRE NITI FORM I LOWER 019X025 T=20 28MM IND 10/PK
00190746076619WIRE NITI FORM I LOWER 018X025 T=20 28MM IND 10/PK
00190746076602WIRE NITI FORM I LOWER 016X022 T=20 28MM IND 10/PK
00190746076596WIRE NITI FORM I LOWER 017X025 T=20 28MM IND 10/PK
00190746076589WIRE NITI FORM I UPPER 021X025 T=20 38MM IND 10/PK
00190746076572WIRE NITI FORM I UPPER 021X025 T=20 34MM IND 10/PK
00190746076565WIRE NITI FORM I UPPER 019X025 T=20 38MM IND 10/PK
00190746076558WIRE NITI FORM I UPPER 019X025 T=20 34MM IND 10/PK
00190746076541WIRE NITI FORM I UPPER 018X025 T=20 38MM IND 10/PK
00190746076534WIRE NITI FORM I UPPER 018X025 T=20 34MM IND 10/PK
00190746076527WIRE NITI FORM I UPPER 016X022 T=20 38MM IND 10/PK
00190746076510WIRE NITI FORM I UPPER 016X022 T=20 34MM IND 10/PK
00190746076503WIRE NITI FORM I UPPER 017X025 T=20 38MM IND 10/PK
00190746076497WIRE NITI FORM I UPPER 017X025 T=20 34MM IND 10/PK
00190746076480WIRE NITI FORM III UPPER 014X025 IND 10/PK
00190746076473WIRE NITI FORM III UPPER 014X025 10/PK
00190746076466WIRE NITI FORM III LOWER 014X025 IND 10/PK
00190746076459WIRE NITI FORM III LOWER 014X025 10/PK
00190746076442WIRE NITI FORM I UPPER 020X020 IND 10/PK
00190746076435WIRE NITI FORM I UPPER 020X020 10/PK
00190746076428WIRE NITI FORM I LOWER 020X020 IND 10/PK
00190746076411WIRE NITI FORM I LOWER 020X020 10/PK
00190746072512WIRE NITI FORM III LOWER 021X025 100/PK
00190746072505WIRE NITI FORM III LOWER 020X020 100/PK
00190746072499WIRE NITI FORM III LOWER 019X025 100/PK
00190746072482WIRE NITI FORM III LOWER 018X025 100/PK
00190746072475WIRE NITI FORM III LOWER 018X018 100/PK
00190746072468WIRE NITI FORM III LOWER 017X025 100/PK
00190746072451WIRE NITI FORM III LOWER 016X022 100/PK
00190746072444WIRE NITI FORM III LOWER 016X016 100/PK
00190746072437WIRE NITI FORM III UPPER 021X025 100/PK
00190746072420WIRE NITI FORM III UPPER 020X020 100/PK
00190746072413WIRE NITI FORM III UPPER 019X025 100/PK
00190746072406WIRE NITI FORM III UPPER 018X025 100/PK
00190746072390WIRE NITI FORM III UPPER 018X018 100/PK
00190746072383WIRE NITI FORM III UPPER 017X025 100/PK
00190746072376WIRE NITI FORM III UPPER 016X022 100/PK
00190746072369WIRE NITI FORM III UPPER 016X016 100/PK
00190746072352WIRE NITI FORM III LOWER 020 100/PK
00190746072345WIRE NITI FORM III LOWER 018 100/PK
00190746072338WIRE NITI FORM III LOWER 016 100/PK

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