Thank you for your interest in Case Medical, Inc. We are a FDA registered, ISO 13485 certified manufacturer of sterilization cases and procedure trays with the CE Mark for international distribution and 510(k) pre-market clearance for our products. Below you will find the answers to some of the most frequently asked questions.
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What sterilization methods are we approved to use with the SteriTite container system?
We have 510(k) pre-market clearance for steam prevac & gravity; EO and STERRAD gas plasma sterilization. See attached Summary Statements of Safety and Effectiveness.
What guarantees are on the container systems, and their parts?
Case Medical's product line is guaranteed to be free of functional defects in workmanship and materials when used as directed for its intended purpose. Lid gaskets and filter ring gaskets are under warranty for three years. MediTray products are under warranty for one year. See attached Product Warranty Statement.
What validation studies on the sets do we have?
Studies included testing with maximum and minimum load, surfaces and lumens, ability to stack containers three high in the autoclave and EO sterilizers. Validation testing demonstrated effective sterilant penetration as well as barrier properties. SteriTite containers as well as inserts were validated for safety, effectiveness and material compatibility. See attached Summary Statements of Safety and Effectiveness.
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