BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ceretone

    DI: 00860010331057 · Model: Style · Audicon Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ceretone
    Primary DI
    00860010331057
    Version / Model
    Style
    Company Name
    Audicon Corporation
    Labeler DUNS
    118836847
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-09
    Public Version
    1
    Public Version Date
    2025-01-17
    Public Version Status
    New
    Public Device Record Key
    27e15e57-b430-4ab4-9d6f-1259b8ccef27

    Device Description

    OTC Rechargeable Hearing Aid

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QUF Hearing Aid, Air-Conduction, Over The Counter

    GMDN Terms

    Code Name
    34672 Air-conduction hearing aid, in-the-ear

    Identifiers

    Type ID
    Primary 00860010331057
    Package 10860010331054