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The SUREcore Plus Biopsy Instrument is intended for use in obt tissue such as liver, kidney, and prostate. It is not intended for use in bone.

The SUREcore Plus biopsy instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Plus device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can re-energize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue. When the user has determined that sufficient amount of tissue has been obtained, the SUREcore Plus device is disposed in accordance with local and facility policies and procedures. The device is single-use only and is not to be resterilized by the user.

The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone.

The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.

The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.

The Repris Bladder Injection System consists of an introducer that is positioned onto the shaft of a cystoscope lens, a needle that is contained within a lumen in the wall of the introducer, and a metered syringe. The fully assembled Repris device has an overall length of 32.4 cm (12.75 inches); the introducer's working length is 20.4 cm (8.06 inches). External to the introducer is a metered syringe that is attached to the luer connection at the proximal end of the needle. The metered syringe delivers a pre-determined dose for each of the multiple injection sites as the plunger is advanced. The syringe provides the user with a tactile and auditory feedback when the exact dose is delivered.