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The AdiPrep™ Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The AdiPrep™ Adipose Transfer System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired. • Neurosurgery • Gastrointestinal Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General surgery - Orthopedic Surgery . - . Gynecological Surgery - Thoracic Surgery . - Laparoscopic Surgery . - Arthroscopic Surgery ●

The Harvest AdiPrep Adipose Transfer System consists of a disposable process pack to be utilized with the SmartPReP2 centrifuge. The process pack is a sterile (EtO) single use disposable pack used for the aspiration, harvesting, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow. The SmartPReP Centrifuge System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.

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The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate.

The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Harvest Graft Delivery System consists of a Graft Syringe/Infusion Chamber with pre-seated polymer plug and removable plunger and syringe cap; a dual liquid applicator; female/female luer connector and push rod. A commercially available bone marrow aspirate needle is supplied separately for use with the system.

The SmartJet Grafting Liquid Applicator is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

The Harvest SmartJet Grafting Liquid Applicator is provided sterile in a sealed pouch and is intended for a single use. The device consists of the following components: Two commercially available disposable medical piston syringes. Applicator Tip (spray or dual cannula) Handle Frame, and Plunger Clip