BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    TREWAVIS SURGICAL INSTRUMENTS PTY LTD.

    Reg #: 9680770 · FEI: 3006795395 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    TREWAVIS SURGICAL INSTRUMENTS PTY LTD.
    Registration Number
    9680770
    FEI Number
    3006795395
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21 Michellan Court
    City
    Bayswater Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K902097

    Owner / Operator

    Firm Name
    TREWAVIS SURGICAL INSTRUMENTS PTY LTD
    Operator Number
    9011291
    Address
    21 Michellan Court
    City
    Bayswater
    State
    Victoria
    Postal Code
    3153
    Country
    AU
    Correspondent
    GENE G THALAPPILLIL

    US Agent

    Business Name
    NORTHSTAR SURGICAL, INC.
    Contact Name
    Ann Laird
    Address
    4978 LINCOLN DRIVE
    City
    Edina
    State
    MN
    ZIP
    55436
    Country
    US
    Email
    [email protected]
    Phone
    952 9281490

    Products

    Device Name Product Code
    Instrument, Biopsy, Suction FCK
    Retractor, Self-Retaining FFO
    Forceps, Biopsy, Non-Electric FCL

    Proprietary Names

    Trewavis Surgical JC Medical KEON COHEN RETRACTOR Sterile Single Use Rectal Suction Biopsy Tool SBT 200 Sterile Single-Use Rectal Suction Biopsy System Rectal Suction Biopsy Tool Sterile Single Use SBT-200

    Establishment Types

    Manufacture Medical Device