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510(k) Data Aggregation
K Number
K110369Device Name
INDISTRIP GREEN
Manufacturer
Date Cleared
2011-05-06
(87 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
INDILAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.
Device Description
The INDISTRIP Green Process Indicator for sterilization consists of a metal free indicator ink printed onto white vellum. The indicator changes color from yellow to black when exposed to steam sterilization conditions. Unprocessed indiryclife to stable for atleast 6 months when stored at 30℃ or less. The postprocessed indicator color is stable for at least 6 months after exposurer to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilize cycles of. The indicator does not respond to dry heat or ethylene oxide.
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