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The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days. Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes. Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container. Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.

The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days. The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used as described in the instructions for use. Reusable trays and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container. The Jewel Precision Reusable Rigid Sterilization Container System comprises a sealed sterilization container consisting of a base, cover, filter retainers, single use replaceable paper filters, and accessories consisting of inner trays, and support brackets. Support brackets are configured to securely support container contents, and are secured to inner trays with stainless steel screws and cap nuts. The container is designed to allow efficient exposure of the tray's contents to sterilant gas during the sterilization process, and to contain and protect reusable surgical instruments during sterilization, transport, and storage. The cover incorporates a sealing gasket, and is secured to the base with latches which lock in place. The latching mechanism places a load on the gasket, which is held in compression against the top surface of the container base, maintaining sterile integrity and preventing unwanted separation. The cover also incorporates an alignment flange along its perimeter, which ensures correct alignment of the cover with the container bottom. Provisions are made on the external container surfaces for the use of user provided Sterilizer Load Data Cards and user provided Tamper Evident Locks, through the incorporation of stainless steel Load Data Card Holders and stainless steel hasp and pin studs are designed to fit standard autoclaves, and are manufactured of materials capable of withstanding repeated steam sterilization cycles. The containers and accessories are manufactured from materials which are suitable for use with Pulsed Pre-Vacuum Steam Sterilization methods. Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared under K800123, which allows ingress and egress of sterilant gas while providing a microbial barrier. The Filter media is single use only. The Jewel Precision Reusable Rigid Sterilization Container System is used to organize, protect, and transport surgical instruments during steam sterilization and subsequent storage. The Jewel Precision Reusable Rigid Sterilization Container System maintains sterility of enclosed instruments, having been validated for a period of 30 days post sterilization, using containers previously subjected to more than 100 sterilization usage cycles. The Jewel Precision Reusable Rigid Sterilization Container System is intended for sterilization of non-porous and porous items, e.g. scissors, hooks, probes, extractors, suction instruments, drivers, rasps, obturators, etc. The container does not come into direct patient contact while in use.