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510(k) Data Aggregation
K Number
K161024Device 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
880.2800Why 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
K140940Device Name
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
Manufacturer
CANADIAN TECHNICAL TAPE, LTD.
Date Cleared
2014-10-27
(196 days)
Product Code
JOJ
Regulation Number
880.2800Why 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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