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Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only

Reprocessed Used Disposable Sequential Compression Sleeves

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract. MDS reprocessed biopsy forceps are disposable unless reprocessed again by MDS.

MDS intends to market Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by MDS to MDS protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). MDS is a "third party reprocessor" and reprocesses used, single-use medical devices. MDS believes that Used Disposable Biopsy Forceps can be considered "reusable - by MDS" as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Biopsy forceps are long instruments with a small jaw type mechanism on one end and a handle mechanism on the other. Forceps are designed to collect tissue samples.

Reprocessed trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. Reprocessed trocars are single patient use devices.

Reprocessed Disposable Trocars

Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.

Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.

Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.

The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.