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510(k) Data Aggregation

    K Number
    DEN130004
    Device Name
    MOERAE SURGICAL MARKING PEN
    Manufacturer
    MOERAE MATRIX, INC.
    Date Cleared
    2014-12-18

    (591 days)

    Product Code
    PDW
    Regulation Number
    878.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOERAE MATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoPrep Surgical Marking Pen is intended for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft.
    Device Description
    The VasoPrep Surgical Marking Pen is a single patient use sterile prescription use only marker intended for use on veins prior to or during Coronary-Assisted Bypass Graft (CABG) surgery. The marker (Figure 1) consists of a pen body, barrel, wick and cap with a wide chisel style applicator tip for delivery of ink to mark internal tissue. The formulation is non-toxic as used and is comprised of an ink material (FD&C Blue Dye #1) compounded into a carrier material (i.e., solvent). The wide chisel tip can deliver either a thin line of ink for precise marks or can be rotated 90° to deliver a wide stripe of ink.
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    K Number
    K131659
    Device Name
    MOERAE VEIN PREPARATION KIT
    Manufacturer
    MOERAE MATRIX, INC.
    Date Cleared
    2014-03-03

    (270 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOERAE MATRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
    Device Description
    The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.
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