BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Adhesive Pad

    DI: 04260759930515 · Model: E003001 · Fiagon GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Adhesive Pad
    Primary DI
    04260759930515
    Version / Model
    E003001
    Catalog Number
    E003001
    Company Name
    Fiagon GmbH
    Labeler DUNS
    312623008
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2024-09-02
    Public Version
    1
    Public Version Date
    2024-09-10
    Public Version Status
    New
    Public Device Record Key
    ff16ba74-4826-454a-8b3c-f6a7d61ebea1

    Device Description

    Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PGW Ear, Nose, And Throat Stereotaxic Instrument

    GMDN Terms

    Code Name
    45199 Multi-purpose stereotactic surgery system

    Identifiers

    Type ID
    Unit of Use 14260759930512
    Primary 04260759930515
    Previous EFIAE0030011

    Customer Contacts

    Phone
    +13364282241
    Email
    [email protected]