BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Aurix Ear Domes

    DI: 00627908080080 · Model: 100004 · Vivosonic Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aurix Ear Domes
    Primary DI
    00627908080080
    Version / Model
    100004
    Company Name
    Vivosonic Inc
    Labeler DUNS
    201740425
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2020-04-21
    Public Version Status
    Update
    Public Device Record Key
    f6e18452-03f9-49ec-bf50-f797c8527b66
    Distribution End Date
    2020-04-20

    Device Description

    Ear domes for use with the Aurix system (DI: 00627908080011) The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10)

    Device Characteristics

    Single Use
    Yes
    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
    No
    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
    GWJ Stimulator, Auditory, Evoked Response

    GMDN Terms

    Code Name
    35747 Evoked-potential audiometer

    Identifiers

    Type ID
    Primary 00627908080080