BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GN Otometrics A/S

    DI: 05713315005244 · Model: 1085 Vision Denied Solution Kit (50 sets) · Natus Medical Denmark ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    GN Otometrics A/S
    Primary DI
    05713315005244
    Version / Model
    1085 Vision Denied Solution Kit (50 sets)
    Catalog Number
    8-35-47100
    Company Name
    Natus Medical Denmark ApS
    Labeler DUNS
    306633756
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-09
    Public Version
    5
    Public Version Date
    2025-10-30
    Public Version Status
    Update
    Public Device Record Key
    f0bf714d-2722-41bb-9373-fe139bf69fb8

    Device Description

    1085 Vision Denied Solution Kit (50 sets)

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWN Nystagmograph

    GMDN Terms

    Code Name
    11479 Electronystagmograph

    Identifiers

    Type ID
    Primary 05713315005244