BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DeRoyal

    DI: 00749756060080 · Model: 0557D31 · 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
    00749756060080
    Version / Model
    0557D31
    Catalog Number
    0557D31
    Company Name
    DEROYAL INDUSTRIES, INC.
    Labeler DUNS
    096372255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-13
    Public Version
    1
    Public Version Date
    2023-01-23
    Public Version Status
    New
    Public Device Record Key
    86df8a42-ef62-4b6a-9194-e87c610aa5d8

    Device Description

    Wrist Splint

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ILH SPLINT, HAND, AND COMPONENTS

    GMDN Terms

    Code Name
    16210 Hand/finger splint, single-use

    Identifiers

    Type ID
    Primary 00749756060080