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The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: · Gravity steam at 250°F/121°C for 30 minutes. · Pre-vacuum steam at 270°F/132°C for 4 minutes. • 100% ethylene oxide (EO) with a concentration of 725-735 mg/l at 131°F/55°C and 40%-80% relative humidity for 60 minutes. - · Advanced Sterilization Products (ASP) STERRAD® 100S system. · Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles. · Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles. · Advanced Sterilization Products (ASP) STERRAD® 200 System. • Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems. · TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load) The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.