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The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles: Enclosure Pivot System Sterilization Tray Cycle Pre-Vacuum 132°C (270°F) Temperature Sterilization Time 4 minutes Pressure 2-15 PSIA Minimum Dry Time 30 minutes in chamber The maximum validated product loads for the trays in containers are as follows: 2-Level Rack, Level 2, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 3 each 39.1960.02, RP OST Tool Rod, 3 each 39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each 39.1960.51.02 RP OST Tool 1D RH 22mm, 1 each 39.1960.20.01 RP OST Angle 162mm, 1 each 39.1960.20.02 RP OST Angle 19mm, 1 each 39.1960.20.03 RP OST Angle 21.5mm , 1 each 39.1960.40.01 RP TM Spike Blade, 1 each 39.1960.60.01 OST Reverse Blade 11mm, 1 each 39.1960.60.02 OST Reverse Blade 16mm, 1 each 39.1960.30.01 RP OST Tool Curve 16mm, 1 each 39.1960.30.02 RP OST Tool Curve 19mm, 1 each 39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each 39.1960.10.01 RP OST Straight 20mm, 1 each 39.1960.10.02 RP OST Straight 40mm, 1 each 39.1960.10.03 RP OST Straight 43mm, 1 each 39.1960.10.04 RP OST Straight 47.5mm, 1 each 39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each 39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each 2-Level Rack - Level 1, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 1 each 39.1960.02, RP OST Tool Rod, 1 each 39.1960.05, Retractor, 1 each 39.1960.07, RP OST System, 1 each 39.1960.70.01 RP Curved Hip Long, 1 each 39.1960.70.02 RP Curved Hip Short, 1 each 39.1960.70.03 RP Curved Hip, 1 each

The RP Medical Pivot System Sterilization Tray System platform is designed to be compatible with the RP Medical Pivot Implant Extraction Osteotome surgical instruments. The Pivot System Sterilization Tray is constructed from thermoplastic plastics, aluminum and stainless steel. Each tray has evenly distributed steam holes. Individuals instruments were designed to slide into 2 level storage racks. The racks have handles on the side to facilitate carrying. The Pivot System Sterilization Tray has a sliding latch mechanism to facilitate containment. Each storage rack is set to a specific configuration and have stainless steel and silicone brackets and silkscreened artwork to assist the end user in correct placement of the instruments. The rack is designed to fit in a standard autoclave. The Pivot System Sterilization Tray System is reusable and provided in a non-sterile condition.