BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MEDONE ULTRA

    DI: 08052286423402 · Model: MU18200-K0 · MEDAX SRL UNIPERSONALE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MEDONE ULTRA
    Primary DI
    08052286423402
    Version / Model
    MU18200-K0
    Company Name
    MEDAX SRL UNIPERSONALE
    Labeler DUNS
    440211428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-05
    Public Version
    1
    Public Version Date
    2020-05-13
    Public Version Status
    New
    Public Device Record Key
    e0f7811b-d1ab-439b-92ed-e5f5e8006465

    Device Description

    Soft Tissue Programmable Automatic Biopsy System 18G X 200 mm

    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
    Yes
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNW Instrument, Biopsy

    GMDN Terms

    Code Name
    16835 Soft-tissue biopsy procedure kit, non-medicated

    Identifiers

    Type ID
    Package 18052286423409
    Primary 08052286423402

    Premarket Submissions

    Submission Number Supplement Number
    K192101 000