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The Stat-Mat® Minor multipurpose surgical instrument tray is used for loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses. The Stat-Mat® Minor is designed using plastic and metal materials that can be reused with prevacuum or gravity displacement steam sterilization methods. The Stat-Mat® Minor should be used only with FDA-cleared and legally marketed sterilization wraps that have been cleared for the sterilization cycles listed below. The Stat-Mat® Minor has been validated with the Dextex II Sterilization Wrap [K800123]. The base containing organized surgical instrumentation can be placed directly on the back table or onto a Mayo Tray. Instruments with lumens were not tested in the Stat-Mat® Minor validation process and are therefore not recommended for use with the Stat-Mat® Minor. Sterilization cycle parameters: | Cycle Type | Temperature | Sterilization<br>Time | Pre-Vac Pulses | Dry Time | |------------|---------------|-----------------------|----------------|------------| | Gravity | 250°F (121°C) | 30 minutes | none | 30 minutes | | Pre-vacuum | 270°F (132°C) | 4 minutes | 4 | 30 minutes |

The Stat-Mat® Minor is a multipurpose surgical instrument tray that consists of three primary components: a base, cover, and instrument roll. The base and cover are composed of Radel plastic. which meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with standard steam sterilization methods. The instrument roll is composed of aluminum and is used to keep ringed instruments open during sterilization. The Stat-Mat® does not contact the patient.