BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GN Otometrics A/S

    DI: 05713315006005 · Model: 1093, Headset HS3 · Gn Otometrics A/S
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GN Otometrics A/S
    Primary DI
    05713315006005
    Version / Model
    1093, Headset HS3
    Catalog Number
    8-61-20200
    Company Name
    Gn Otometrics A/S
    Labeler DUNS
    306633756
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-15
    Public Version
    3
    Public Version Date
    2020-12-03
    Public Version Status
    Update
    Public Device Record Key
    66917e51-43ea-4f99-829c-0e0cf263689b

    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
    ERA Otoscope

    GMDN Terms

    Code Name
    63263 Auditory canal scanner

    Identifiers

    Type ID
    Primary 05713315006005