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The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below: | Cycle Type | Exposure Temperature | Exposure Time (minutes) | Minimum Dry Time (minutes) | Compatible Sterile Barriers | |---|---|---|---|---| | Pre-Vacuum | 132 °C (270 °F) | 4 minutes | 20 minutes | Wrap(s) | | Gravity | 121 °C (250 °F) | 30 minutes | 20 minutes | Wrap(s) |

The MicroAire PAL Sterilization Case is a non-surgical, non-patient contacting, accessory to the already existing PAL (Power-Assisted Liposuction) System (cleared for market under K212024, K171286 and K220318), designed to contain reusable surgical instruments during steam sterilization. The case is designed to contain four (4) PAL Multi-Use Cannulas, one (1) PAL Electric Handpiece, and one (1) PAL Handpiece Cable. The subject product scope only includes the sterilization case, constructed of a separable base and lid, as illustrated in Figure 11-A. The PAL Sterilization Case (subject device) is a stainless-steel case comprised of a separable lid and base. These two components latch together via the latch mechanisms on either side of the base which mate with the flanges on either side of the lid. Inside the case there are silicone mounts for a PAL handpiece, cable, and 4 cannulas (30 cm or less in length). The sterilization case is used to steam sterilize its contents via standard gravity or dynamic air removal autoclave processes. The subject device is a non-surgical, non-patient contacting, accessory device to the MicroAire PAL System. The subject device allows a user to organize and transport PAL reusable surgical instruments before, during, and after steam sterilization. The case is provided non-sterile and contains silicon mounting brackets to keep the devices in place, and a perforated stainless-steel enclosure to allow penetration of steam. The case has an overall footprint of approximately 16" x 6" x 2". Its construction of 1mm thick stainless steel and silicone make it lightweight and easy to transport when fully loaded with instruments. The lid also has two carrying handles on its lid for easy transport.

The AESCULAP Aicon® Container is a reusable rigid sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below: - Ethylene Oxide (EtO) - STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex - STERIS V-PRO 60: Lumen, Non- Lumen, Flex - STERIS V-PRO S2 Non-Lumen - STERRAD 100NX: Standard, Express, Flex, Duo - STERRAD NX: Standard, Advanced - STERRAD 100S - STERIZONE VP4 - PreVac Steam The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container. The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU. The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number. - The first digit of the model number designates the container length. - The second digit designates the height. - The last digit identifies the model and features. - Standard solid bottom container, designated by the "0" at the end of the product number. - Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram. The JJ Series uses the same lids for the Standard and the EDS container bottoms. Container Size | Standard Container | EDS Container | Lid ---|---|---|--- Full Size 4" | JJ110 | JJ111 | JJ410 Full Size 6" | JJ120 | JJ121 | Full Size 8" | JJ130 | JJ131 | Full Size 10" | JJ140 | JJ141 | Three-Quarter Size 4" | JJ310 | JJ311 | JJ430 Three-Quarter Size 6" | JJ320 | JJ321 | Three-Quarter Size 8" | JJ330 | JJ331 | Three-Quarter Size 10" | JJ340 | JJ341 | Half Size 4" | JJ210 | JJ211 | JJ420 Half Size 6" | JJ220 | JJ221 | Half Size 8" | JJ230 | JJ231 | Half Size 10" | JJ240 | JJ241 | The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom. The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures. Notes: - Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed. - Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms. - AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards. - Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below: - Prevac Steam - 270°F, 4 min exposure - 15-minute dry time ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm. DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant. Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle. ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion. The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.

The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers). The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C. The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap). Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices. Sterilization parameters: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time. Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface. Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used. The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle: - Temperature: 270°F/132°C - Exposure time: 4 minutes. - Drying time: 20 minutes. - The cassettes are not to be stacked during sterilization. KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively. Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.

The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices. The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads. The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.

The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.

The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.