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The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is an assembly of medical products sterilized within a Tyvek®/polyethylene pouch. The trays are sterile, disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the tray are commonly used for wound management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray.

The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.

The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable. The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.