BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    nuance audio

    DI: 08056262282489 · Model: AAW0002EL · LUXOTTICA GROUP SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    nuance audio
    Primary DI
    08056262282489
    Version / Model
    AAW0002EL
    Company Name
    LUXOTTICA GROUP SPA
    Labeler DUNS
    436825376
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-13
    Public Version
    1
    Public Version Date
    2025-05-21
    Public Version Status
    New
    Public Device Record Key
    e8bb077c-d8e5-4c97-9eac-e538d29471db

    Device Description

    Remote control accessory

    Device Characteristics

    Single Use
    No
    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
    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
    QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

    GMDN Terms

    Code Name
    57885 Hearing aid/implant system remote control

    Identifiers

    Type ID
    Primary 08056262282489