BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DD45-300 Headphones

    DI: 00817020021065 · Model: M015053 · INTELLIGENT HEARING SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    DD45-300 Headphones
    Primary DI
    00817020021065
    Version / Model
    M015053
    Company Name
    INTELLIGENT HEARING SYSTEMS CORP.
    Labeler DUNS
    154870455
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-10
    Public Version
    1
    Public Version Date
    2021-02-18
    Public Version Status
    New
    Public Device Record Key
    7b6a1850-6e01-47fa-bbed-46a20d019b8e

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EWO Audiometer

    GMDN Terms

    Code Name
    41237 Earphone, supra-aural

    Identifiers

    Type ID
    Primary 00817020021065