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The Tumark® Vision, the Tumark® Professional, the Tumark® Professional Q-Shape are intended to attach a marker to soft breast tissue and axillary lymph nodes, following an open or a percutaneous procedure to radiographically mark the location of the surgical site. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

The Tumark® Vision, Tumark® Professional, Tumark® Q, and Tumark® Professional Q-Shape are sterile products for single use only. Each consists of a non-absorbable nickel-titanium clip marker, an introducer cannula, and a plastic handle. The clip marker is contained within the cannula when new and unopened. The cannula tip is bevelled, has markings 1 cm apart for measuring depth, and a textured surface behind the tip. The handle has a slide button for one-handed marker placement and a safety catch system to prevent premature deployment. The clip markers have different shapes: spherical (Tumark Vision), U-shape (Tumark Professional), Q-shape (Tumark Q), and Q-shaped (Tumark Professional Q Shape). The symbol of the clip marker shape is depicted on the handle.

Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.

Tumark for Eviva and Tumark for Brevera are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The introducer cannula has a blunt tip and can only be used together with an introducer. The handle is equipped with a slide-button which allows for a one handed placement of the marker by pressing it forward. A safety catch system prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the marker.

The Tumark Vision is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

The Tumark Vision is a sterile, sinqle use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handle. It is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not intended to be used with magnetic resonance imaging (MRI) techniques.

The TUMARK® Flex is intended for radiographically and radiologically percutaneous marking of soft tissue, especially breast tissue, via a clip marker. The TUMARK® Flex is not indicated to be used with magnetic resonance imaging (MRI) techniques.

The TUMARK® Flex is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable Nitinol clip-marker, a guide wire or tube and a handle with ejection mechanism. The guide wire is composed of a flexible tube, a distal ramp made of surgical high-grade steel with an opening for releasing the clip marker and a depth stopper with snap-in tip. The guide tube is composed of a tube section, a distal ramp made of surgical steel with an opening for releasing the clip marker, and a marking line, which shows the orientation of the ejection port for the clip marker. The handle is provided with a slider by means of which the clip can be released. The clip marker is situated in the distal ramp. TUMARK® Flex can be used together with, e.g. ultrasound and stereotactic X-ray imaging procedures. The TUMARK® Flex is not indicated to be used in Magnetic Resonance Tomography (MRT). However, the clip marker placed in the patient can be exposed to a magnetic field of up to 3.0 Tesla, for instance in follow-up examinations.

The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.

The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the proposed devices will be delivered with a protective tube.

The Tumark® Professional and MRI Tumark® Professional are intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. The devices are indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. Only the MRI Tumark® Professional is indicated to be used in Magnetic Resonance Imaging (MRI) procedures.

The Tumark® Professional and MRI Tumark® Professional are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The Tumark® Professional is not indicated to be used in Magnetic Resonance Imaging (MRI) procedures. The MRI Tumark® Professional is MRI Safe and indicated to be used during MRI procedures. The introducer cannula which will be available in stainless steel (Tumark® Professional) or cobalt-chrome alloy (MRI Tumark® Professional) for use with magnetic resonance imaging techniques is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The cannulas will be available in different lengths. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker. The Tumark® Professional will be available with a U-shaped or X-shaped marker. The MRI Tumark® Professional will only be available with a U-shaped marker.

The Tumark® Professional is intended to attach a marker to soft tissue at the surgical site during an open or a percutaneous procedure. It is indicated for use to radiographically and radiologically mark the surgical location in breasts following an open or percutaneous procedure. It is not indicated to be used with magnetic resonance imaging (MRI) techniques.

The Tumark® is a sterile, single use, preloaded tissue site marking system consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism. The introducer cannula which consists of stainless steel is designed with 1 cm depth marks, a beveled tip and an ultrasound enhancement on the distal end. The handle is equipped with a slide-button which allows for a one handed placement. A safety catch system prevents the slide-button from inadvertently moving forward and therefore prevents a premature deployment of the marker.