NT3 857-VX-2125W

GUDID 00190746076718

WIRE NITI VLP UNIV 021X025 IND 10/PK

AMERICAN ORTHODONTICS CORPORATION

Orthodontic wire

• Primary Device ID: 00190746076718
• NIH Device Record Key: b5d0a1c4-4638-425c-9564-15e7e04fd08c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NT3
• Version Model Number: 857-VX-2125W
• Catalog Number: 857-VX-2125W
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 38 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746076718 [Primary]

FDA Product Code

• DZC: WIRE, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-02
• Device Publish Date: 2018-01-18

On-Brand Devices [NT3]

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