BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Striate+

    Reg #: 3014015147 · FEI: 3014015147 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHOCELL LIMITED
    Registration Number
    3014015147
    FEI Number
    3014015147
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 191 Murdoch University, South Street, Murdoch
    City
    Perth Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K201241

    Owner / Operator

    Firm Name
    Orthocell Limited
    Operator Number
    10081188
    Address
    Building 191 Murdoch University, South Street, Murdoch
    City
    Perth
    State
    Western Australia
    Postal Code
    6150
    Country
    AU

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Barrier, Animal Source, Intraoral NPL

    Proprietary Names

    Striate+ perFORM

    Establishment Types

    Manufacture Medical Device