BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    RB12 SUCTION RECTAL BIOPSY SYSTEM

    Reg #: 3005921952 · FEI: 3005921952 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AUS SYSTEMS PTY LTD.
    Registration Number
    3005921952
    FEI Number
    3005921952
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 CHARLES ST
    City
    ALLENBY GARDENS South Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K062159

    Owner / Operator

    Firm Name
    AUS SYSTEMS PTY LTD.
    Operator Number
    9076885
    Address
    3 CHARLES ST, --
    City
    ALLENBY GARDENS
    State
    South Australia
    Postal Code
    5009
    Country
    AU
    Correspondent
    PAUL - ZADOW

    US Agent

    Business Name
    SPECIALTY SURGICAL PRODUCTS INC
    Contact Name
    Dawn Nelson
    Address
    1123 NORTH U.S. HIGHWAY
    City
    Victor
    State
    MT
    ZIP
    59875
    Country
    US
    Email
    [email protected]
    Phone
    406 9610102

    Products

    Device Name Product Code
    Instrument, Biopsy, Suction FCK

    Proprietary Names

    RB12 SUCTION RECTAL BIOPSY SYSTEM

    Establishment Types

    Manufacture Medical Device