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The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.

The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.

The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood. The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback. The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement. The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

The Forsvall biopsy needle is intended to collect histological biopsy samples from soft tissue intended for clinical examination. The Forsvall biopsy needle is part of the Forsvall biopsy needle system for prostate biopsy and shall be used together with the Forsvall biopsy gun. The Forsvall biopsy gun is intended to be used by medical professionals, together with the Forsvall biopsy needle, on male patients to obtain soft tissue samples. The Forsvall biopsy gun is part of the Forsvall biopsy needle system for prostate biopsy. The Forsvall biopsy needle system for prostate biopsy is indicated whenever there is a need to obtain prostate biopsy samples.

The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel. By pulling a handle on the Forsvall biopsy gun, the front wagon therein is tensioned and connected to the Forsvall biopsy needle. When tensioning the load pin also moves along a guide curve. When the front wagon is in its loaded position, the load pin has moved the front needle bracket a small distance backwards in the Forsvall biopsy gun. The handle is pulled a second time to tension the rear wagon that is connected to the needle in the Forsvall biopsy needle. A tension is created between the outer tube and the needle in order to force closing of the Forsvall biopsy needle. The purpose is to prevent an interstice from arising in order to prevent accumulation of bacteria. The Forsvall biopsy gun is fired by pushing the trigger, which causes the rear wagon to move forward of the front wagon. This results in the inner part of the needle being forced forward, followed by forward movement of the outer tube. When the Forsvall biopsy gun is fired, the load pin moves the outer tube the final millimeter in order to achieve a soft closing mechanism. On the Forsvall biopsy needle, the outer tube thus stops against the needle head and it is forced closed. The Forsvall biopsy operates by the outer tube stopping against the needle head in the closing motion. Additionally, the final millimeter in the closing motion is a soft close action in order to protect the needle head from too strong forces. To enable the soft closing action, the Forsvall biopsy gun has a design similar to the predicate device.

Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone. Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.

Automatic Core Biopsy Instrument has seven models. Some models are automatic firing, and others have both automatic firing and delay firing options. The structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block, Protective sheath, Adjustable Knob (on some models), Charging handle (on some models), and Security Lock (on some models). Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas. Semi-Automatic Core Biopsy Instrument has two models. It consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded. The Cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas. Disposable Coaxial Biopsy Needle has two models. It consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula, Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional). An adjustable depth stopper is included and is color-coded. It is available in several needle gauge sizes and lengths. It is intended for use as a guiding needle with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible biopsy instrument/needle. The Cutting cannula has numerical scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration. The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained. The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.

The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.

The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.

The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.

The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.

The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use. The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.

The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.

The device is used for drawing osteomedullary substance and/or for bone marrow explantation.

Trap Easy is a bone marrow biopsy needle, consisting of a cannula with cylindrical tip and ergonomic handle, a removable pyramidal stylet, a sample trapping device integrated into the cannula and an extraction wire. The device is used for drawing osteomedullary substance and/or for bone marrow explantation. This device is intended to be used only by experienced and properly trained physicians and is intended to be used exclusively for bone marrow tissue biopsies. The device is available in different models: - 8G x 100 mm - 8G x 150 mm - 11G x 100 mm - 11G x 150 mm Trap Easy is supplied in sterile packaging and is designed for single use, non-reusable. At the end of its use, the device should be disposed of as infectious hospital waste.

The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood. The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement. The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.