BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Therma-Ti Lite

    DI: 00190746027482 · Model: 857-961IW · AMERICAN ORTHODONTICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Therma-Ti Lite
    Primary DI
    00190746027482
    Version / Model
    857-961IW
    Catalog Number
    857-961IW
    Company Name
    AMERICAN ORTHODONTICS CORPORATION
    Labeler DUNS
    044668515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-24
    Public Version
    5
    Public Version Date
    2023-11-20
    Public Version Status
    Update
    Public Device Record Key
    8d922af9-6c2c-47ae-8519-e8563776a55f

    Device Description

    WIRE THERMA TI LITE FORM III UPPER 016 IND 10/PK

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZC WIRE, ORTHODONTIC

    GMDN Terms

    Code Name
    16204 Orthodontic wire

    Identifiers

    Type ID
    Primary 00190746027482

    Customer Contacts

    Phone
    +1(800)558-7687
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    0 – 60 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    High: 38 Degrees Celsius