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    K Number
    K071673
    Device Name
    ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
    Manufacturer
    ONC SOLUTIONS, INC.
    Date Cleared
    2007-07-18

    (29 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONC SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
    Device Description
    ONC Markers exist as a series of individual gold ring members connected over a gold inner wire. The ring members can be of different diameters and different quantities can be joined together to form longer length markers. The markers will range in nominal diameter from 0.35mm to 1.2mm. The markers will range in overall length from 10mm to 60mm. ONC Markers are packaged in two different formats: A. Markers inside sterile packages for single use only B. Markers inside Preplugged Introducer Needles, inside sterile packages for single use only Sterilization is achieved by a validated EO sterilization method.
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