BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ellex

    DI: 09342395001301 · Model: EYECUBED-40MHZKIT · ELLEX MEDICAL PTY LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ellex
    Primary DI
    09342395001301
    Version / Model
    EYECUBED-40MHZKIT
    Company Name
    ELLEX MEDICAL PTY LTD
    Labeler DUNS
    756138509
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d7152b7c-7de7-40ad-986d-ef7dfa392e9f

    Device Description

    40MHZ ACCESSORY KIT

    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
    No
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 09342395001301

    Customer Contacts

    Phone
    999-999-9999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103608 000