BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SELPHYL(R)

    Reg #: 3012453008 · FEI: 3012453008 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FACTOR MEDICAL Inc.
    Registration Number
    3012453008
    FEI Number
    3012453008
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    300 Baker avenue, Suite 300
    City
    Concord
    State
    MA
    ZIP
    01742
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK170096

    Owner / Operator

    Firm Name
    Factor Medical, Inc
    Operator Number
    10051553
    Address
    41 University Drive, Ste 400
    City
    Newtown
    State
    PA
    Postal Code
    18940
    Country
    US

    Products

    Device Name Product Code
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    SELPHYL(R)

    Establishment Types

    Manufacture Medical Device