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Case Medical announces it has received FDA 510k clearance for its SteriTite sealed container system and MediTray products. The new application included use in STERRAD 200, STERRAD NX, TSO3 ozone 125L, and pre vacuum flash sterilization using our disposable filter.
Case Medical was previously cleared for pre vacuum and gravity steam sterilization, ETO, STERRAD 100, 100S, and sealed flash using its FlashTite valve plate. Case Medical now offers a universal sterilization system that is compatible with all current methods of sterilization including steam as well as low temperature. The container system is ideal for standardization, as the same container is fully compatible and validated with all current sterilization methods.
Furthermore, the SteriTite container system meets sterilizer manufacturers’ recommendations for processing of surfaces as well as lumens, including rigid and flexible endoscopes. Case Medical has continued to offer the healthcare community innovative and cost effective sterilization solutions that are ideal for standardization.
Case Medical, Inc. is a leader in advanced container system design, and is committed to developing, manufacturing and implementing safe and effective sterilization systems. The company has numerous GPO contracts including Novation, Med Assets, Broadlane, Health Trust, Premier and VA/FSS/GOV for sterilization containers. Case Medical has validated its products in independent laboratories and university studies to achieve a 6-log reduction in bioburden and a >99.9 percent reduction in organic soil.
Source: Case Medical