BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DeRoyal

    DI: 00749756374347 · Model: EU04021-U8 · DEROYAL INDUSTRIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DeRoyal
    Primary DI
    00749756374347
    Version / Model
    EU04021-U8
    Catalog Number
    EU04021-U8
    Company Name
    DEROYAL INDUSTRIES, INC.
    Labeler DUNS
    096372255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-04
    Public Version
    1
    Public Version Date
    2023-02-13
    Public Version Status
    New
    Public Device Record Key
    6aef76f7-5682-4ea9-938c-13e35ed9d5ac

    Device Description

    Patella Stabilizer

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITQ JOINT, KNEE, EXTERNAL BRACE

    GMDN Terms

    Code Name
    41065 Knee support orthosis

    Identifiers

    Type ID
    Primary 00749756374347