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5. 510(K) Summary of Safety and Effectiveness JN2421 Sterility Universal Container System with Median Products for Amoco PRO 1 Plus and AMOCO PRO Max, in Nonlumen and Flexible Cycle Date Prepared:
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How to fill out steritite universal container system

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How to fill out steritite universal container system:

01
Start by making sure the container is clean and free from any debris or contaminants.
02
Place the items or materials that need to be sterilized inside the container, ensuring they are arranged properly and there is enough space between them for proper sterilization.
03
Close the lid of the container securely, ensuring it is tightly sealed to prevent any leakage or contamination during the sterilization process.
04
Follow the recommended sterilization method for the steritite universal container system, which may include using steam autoclave, ethylene oxide sterilizer, or hydrogen peroxide plasma sterilizer.
05
Place the closed container in the sterilization device and start the sterilization cycle as per the manufacturer's instructions, ensuring proper temperature and pressure settings are selected.
06
Monitor the sterilization process to ensure it is completed successfully and the required sterilization parameters are met.
07
Once the sterilization cycle is complete, allow the container to cool down before handling it.
08
After cooling, the steritite universal container system can be safely opened, and the sterilized items can be used or stored as needed.

Who needs steritite universal container system?

01
Medical professionals and healthcare facilities such as hospitals, clinics, and dental offices require steritite universal container systems to ensure the safe and effective sterilization of medical instruments and equipment.
02
Laboratories and research facilities that deal with biological samples and sensitive materials may also benefit from using steritite universal container system to maintain sterility and prevent contamination.
03
Veterinary clinics and animal hospitals may utilize steritite universal container systems to sterilize surgical instruments and equipment used in animal care.
04
Pharmaceutical companies and manufacturing facilities that produce sterile drugs or medical devices may rely on steritite universal container systems to maintain the sterility of their products during manufacturing and packaging processes.
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Steritite universal container system is a system used for the proper containment and disposal of medical waste.
Medical facilities, laboratories, and other entities that generate medical waste are required to file the steritite universal container system.
To fill out the steritite universal container system, entities must provide information about the type and quantity of medical waste generated, as well as details about the disposal methods used.
The purpose of the steritite universal container system is to ensure that medical waste is properly contained, transported, and disposed of in order to protect public health and the environment.
Information that must be reported on the steritite universal container system includes the type and quantity of medical waste generated, the disposal method used, and any tracking or disposal information.
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