BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORJ

    DI: D115F202021 · Model: F202-02 · Fortune Worldwide LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ORJ
    Primary DI
    D115F202021
    Version / Model
    F202-02
    Company Name
    Fortune Worldwide LLC
    Labeler DUNS
    949163229
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-23
    Public Version
    1
    Public Version Date
    2023-01-31
    Public Version Status
    New
    Public Device Record Key
    7630cd61-87a2-4752-8352-69c985a2c80c

    Device Description

    Orthodontic Metal Crimp Stop for Teeth Correction

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DZD Tube, Orthodontic

    GMDN Terms

    Code Name
    31759 Orthodontic tube

    Identifiers

    Type ID
    Primary D115F202021