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    K Number
    K161024
    Device Name
    Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
    Manufacturer
    Canadian Technical Tape, Ltd.
    Date Cleared
    2016-06-28

    (77 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Canadian Technical Tape, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
    Device Description
    The process indicator tape distinguishes between items processed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with green indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.
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    K Number
    K140940
    Device Name
    PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
    Manufacturer
    CANADIAN TECHNICAL TAPE, LTD.
    Date Cleared
    2014-10-27

    (196 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANADIAN TECHNICAL TAPE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Process Indicator Tape for Steam Sterilization is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121ºC for 30 minutes or pre-vacuum sterilizers operating at 132ºC for 4 minutes and 1359C for 3 minutes. The indicator stripes turn dark brown black when sterilization conditions, thus providing an indication of processed items.
    Device Description
    The process indicator tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with white indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.
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