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The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles: | Method | Parameter | Cycle | | |---------------------|--------------------|-----------------------------------|-----------------------------------| | | | Cycle 1 | Cycle 2 | | Pre-vacuum<br>Steam | Enclosure | Double Wrap or<br>Rigid Container | Double Wrap or<br>Rigid Container | | | Temperature | 132°C<br>(270°F) | 134°C<br>(273°F) | | | Sterilization Time | 4 minutes | 3 minutes | | | Dry Time | 30 minutes | 30 minutes | The maximum product load for the tray is as follows: | Tray Description | Catalog Number | Maximum Tray<br>Product Load | Maximum Tray<br>Weight | |-------------------------------|----------------|---------------------------------------------------------------------|------------------------| | Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)<br>Cleaning Wire (Qty 1)<br>Torque Wrench (Qty 1) | 6.85 lb |

The Sonopet iQ Sterilization Tray is a reusable device manufactured of perforated stainless steel for the base and lid to allow for sterilization of the enclosed devices. The tray is used to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The tray is compatible with pre-vacuum steam sterilization. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The tray is provided in a non-sterile condition, and must be sterilized prior to use.

The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle: | | Pre-vacuum Steam | |--------------------|---------------------| | Enclosure | Rigid Container | | Temperature | 132°C (270°F) | | Sterilization Time | 4 minutes | | Minimum Dry Time | 30 minutes | | Maximum Weight1 | 19.23 lb. / 8.72 kg | 'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.

The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles: Pre-vacuum Steam Enclosure: Rigid Container1 Temperature: 132°C (270°F), 135°C (275°F) Sterilization Time: 4 minutes, 3 minutes Minimum Dry Time: 30 minutes, 30 minutes Maximum Weight: 25 lbs / 11.36 kg, 25 lbs / 11.36 kg 1 Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid). The maximum validated product loads for the trays in containers are as follows: Configuration: 3-Level Rack - Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container3 Maximum Validated Load Set Contents: 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941), 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941), 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941), 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941), 29-17903 1.7 Orthognathic Plates Inlay, 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941), 29-23905 2.0/2.3 Mini Plates Inlay, Large, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) Configuration: 3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container4 Maximum Validated Load Set Contents: 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941), 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921), 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) 1 Model numbers shown in table are Stryker® model numbers 2 Contents in the validated Tray System inplants (plates, meshes, bone screws, etc.), single-use instruments (drills), and revable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.) 3 Tray system components part of the worst-case configuration Container validation in an Aesculap SterilContainer Base (K446) and Lid (JK489) cleared under K792558 4 Tray system components part of the worst-case configuration in a 1/2 DN Rigid Sterilization in an Aesculap SteriliContainer Base (K346) and Lid (JK389) cleared under K792558 5 No lumened devices were validated within the tray system as part of the Stryker Universal Select Sterilization Tray System does not have any lumen claims.

The Stryker Universal Select Sterilization Tray System consists of anodized aluminum implant modules and inlays to store single-use titanium implants and stainless steel instrument and accessory trays for surgical instrumentation. The implant modules and trays have stainless steel lids which have a slide latch feature. Instrument trays are specific to a set configuration and have stainless steel and silicone brackets, removable screw caddy (for the 90° screwdriver instrument tray), and silkscreened artwork to assist the end user in correct placement of the instruments. Accessory trays are not specific to a set configuration, and have an open area designed for placement of commonly used instruments such as cutters, benders and forceps. The individual components of the system can be organized and stored in a 2-level or a 3-level stainless steel rack. The rack is designed to fit in an Aesculap rigid sterilization container (K792558). The tray system is reusable and provided in a non-sterile condition.

The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles: | No | Method | Cycle | |----|-----------------------|----------------------------| | 1 | Ethylene Oxide (EtO) | Preconditioning Parameters | | | | Temperature (°C) | | | | 55°C (131°F) | | | | Chamber Humidity | | | | 70% RH | | | | Vacuum Set Points | | | | 1.3 psia | | | | Time | | | | 30 minutes | | | | Exposure | | | | Concentration | | | | 725 mg/L, 100% EO | | | | Temperature (°C) | | | | 55°C ±2°C (131°F ±5°F) | | | | Time | | | | 1 hour | | | | Chamber Humidity (%) | | | | 70% RH (50-80%) ±5% | | | | Aeration | | | | Aeration Time | | | | 12 hours | | | | Temperature | | | | 35°C - 54°C (95°F - 129°F) | | 2 | Prevacuum Steam | Cycle 1 | | | | Cycle 2 | | | | Wrapping | | | | Double | | | | Double | | | | Temperature | | | | 132°C (270°F) | | | | 134°C (273°F) | | | | Sterilization Time | | | | 4 minutes | | | | 3 minutes | | | | Dry Time | | | | 30 minutes | | | | 30 minutes | | 3 | Gravity Steam | Cycle 1 | | | | Cycle 2 | | | | Wrapping | | | | Double | | | | Double | | | | Temperature | | | | 132°C (270°F) | | | | 134°C (273°F) | | | | Sterilization Time | | | | 15 minutes | | | | 10 minutes | | | | Dry Time | | | | 30 minutes | | | | 30 minutes | | 4 | STERIS® V-PRO® 1 | Standard | | 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen | | 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen | | 7 | STERRAD® 100S | Standard | | 8 | STERRAD® NX® | Standard | | 9 | STERRAD® 100NX® | Standard | In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY. | Method | Cycle | Cycle 1 | Cycle 2 | |-------------------------------------------------------------------|--------------------|------------------|------------------| | Immediate Use Steam<br>Sterilization (“Flash”)<br>Prevacuum Steam | Wrapping | None | None | | | Temperature | 132°C<br>(270°F) | 134°C<br>(273°F) | | | Sterilization Time | 4 minutes | 3 minutes | | | Dry Time | None | None | The maximum product loads for the trays are as follows: | Tray Description | Catalog Number | Maximum Tray<br>Product Load | Total Loaded<br>Tray Weight | |----------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|-----------------------------| | Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1)<br>Scope (Qty. 2)<br>Adapter (Qty. 2) | 10.58 lbs | | Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1)<br>Scope (Qty. 2)<br>Adapter (Qty. 2) | 10.58 lbs | | Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)<br>Light Cable (Qty. 1)<br>Coupler (Qty. 1) | 8.83 lbs | * Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).

The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods: - Ethylene Oxide (EtO) - Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam . - Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles) - STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) . The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.

Paragon Medical's Surgical Instrument Delivery Systems are containment devices for medical device sterilization, The Systems are constructed of metal and/or plastic with perforations to facilitate steam penetration. They are to be used with an approved sterilization wrap. Sterilization Cycle: Prevacuum 132°C for 4 minutes Dry Time 20-40 minutes

Paragon Medical Surgical Instrument Delivery Systems consist of various sizes of metal, plastic, and combination cases and trays with removable lids. The devices are intended to hold and protect medical instrumentation or devices during steam sterilization processes and subsequent storage and transportation. The products are constructed of durable materials and designed with perforations or slots to allow for steam penetration. They are to be used with an appropriate sterilization wrap.