BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    AUS SYSTEMS PTY LTD.

    Reg #: 3005921952 · FEI: 3005921952 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AUS SYSTEMS PTY LTD.
    Registration Number
    3005921952
    FEI Number
    3005921952
    Status
    Active
    Expiry Year
    2026
    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
    Dilator, Rectal FFP
    Instrument, Biopsy, Suction FCK

    Proprietary Names

    SPECIALTY SURGICAL PRODUCTS, INC. RB12 SUCTION RECTAL BIOPSY SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device