Case Medical Granted FDA Clearance for Container, Product Usage in Sterilizers

Case Medical has been granted Foof and Drug Administration (FDA) 510(k) clearance for its SteriTite container and MediTray products to be used in AMSCO V-PRO 1 Plus and V-PRO maX sterilizers for lumen, non-lumen and flexible cycles.

Case Medical offers a universal sterilization system that is compatible with all current methods of sterilization, including steam as well as low temperature modalities, including V-PRO and STERRAD Sterilization. The company's SteriTite container system meets sterilizer manufacturers' recommendations for surfaces and lumens, including rigid and flexible endoscopes, including flexible lumened devices 1mm or wider and a length up to 1050mm in the flexible cycle of the V-PRO maX.

Formerly an OEM provider to major medical companies for custom fabricated trays, the company offers a wide range of customizable packaging options to healthcare facilities. Case Medical manufactures reusable devices that are safe and effective for patients and staff. The SteriTite container is made from an aircraft-grade of anodized aluminum fully corrosion resistant for maximum durability and a long useful life.  While other sterilization containers may be cleared for low temperature sterilization, the SteriTite container remains the world's only anodized and fully compatible sealed container system.

In addition, the DIN sizing is ideal for containerizing custom fabricated specialty and loaner sets. Case Medical has continued to offer the healthcare community innovative and cost-effective sterilization solutions that are ideal for standardization and contribute to patient safety. Case Medical has also been granted a partnership with the EPA Design for the Environment Program for its line of pH-neutral, environmentally preferred instrument chemistries.

 

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