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XSTAT 30 Pouch is intended to be a hemostatic wound dressing. XSTAT 30 Pouch is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT 30 Pouch is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT 30 Pouch is a temporary device for use up to six (6) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 Pouch is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen: the retroperitoneal space: the sacral space: tissues above the inquinal ligament: or tissues above the clavicle.

The XSTAT 30 Pouch is comprised of the following components: 1. Minisponge Pouches (3 pouches per device) 2. Applicator/Plunger 3. Packaging and Labeling The XSTAT 30 Pouch is a modified version of the company's legally marketed XSTAT 30 Gen2 device (K180051, "XSTAT 30 Gen2' or "predicate device"). The technological differences between the XSTAT 30 Pouch and the predicate device are: - The enclosure of the minisponges in three (3) porous pouches to facilitate their removal from . wounds; - Changing the shape of the minisponges from round to hexagonal; and - Including a radiopaque marker in each pouch in lieu of marking each individual minisponge. . The minisponge pouches are comprised of a tubular knit woven textile constructed with an ultra-high molecular weight polyethylene (UHMWE) fiber. The pouch has a tensile strength of > 200 lbs and is resistant to tearing with surgical tools such as forceps and standard shears. The XSTAT 30 Pouch contains three (3) separate minisponge pouches within each applicator. A medical-grade radiopaque filament (barium sulfate-infused polypropylene) is attached on the interior of each of the three pouches. The minisponges are comprised of a compressed cellulose sponge. When compressed, each minisponge has a height of approximately 5 mm and a surface diameter of 9 mm. Upon contact with blood, the minisponges absorb blood and, if unencumbered, are capable of expanding to a precompressed height of 40-50 mm within approximately 20 seconds. The sponge expands only in length (not width). The applicator and plunger facilitates delivery of minisponge pouches to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and expand to fill and pack the wound. The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deploy the minisponge pouches from the applicator. One (1) applicator is filled with three (3) minisponge pouches and packaged with one (1) plunger in a vacuum-sealed nylon/poly package and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The Instructions for Use (IFU) will be printed on or adhesively affixed to the package.

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds. The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from, immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is NOT indicated for use in the thorax, the pleural cavity, the mediastinum, the abdomen, the retroperitoneal space, the sacral space, tissues above the inguinal ligament; or tissues above the clavicle. XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. XSTAT 12 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT 12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk from immediate life-threatening hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament, or tissues above the clavicle.

The XSTAT 30 device consists of an applicator that facilitates delivery of minisponges to external bleeding wounds. The applicator with a telescoping handle is filled with ~ 92 minisponges and packaged in a vacuum-sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The XSTAT 30 3-pack consists of three (3) applicators in an individually sealed foil pouch and terminally sterilized by gamma radiation. The Instructions for Use ("FU") are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging. The XSTAT 30 1-pack consists of one (1) applicator in an individually sealed foil pouch and terminally sterilized by gamma irradiation. The Instructions for Use (IFU) are printed on the outside of the sterile packaging. One (1) product insert summarizing preclinical testing and one (1) casualty card is included with the packaging. The XSTAT 12 device consists of an applicator and plunger that facilitate delivery of minisponges to external bleeding wounds. Individual applicators are filled with minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, and terminally sterilized by gamma radiation to a sterility assurance level of 10 °. The XSTAT 12 device consists of vacuum-sealed, gamma radiated, inner pouches which are packaged inside a larger outer pouch as a three (3) pack or one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch. The XSTAT devices comprise standard, regenerated cellulose medical sponge that is compressed and formed into minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. Each minisponge contains a radiopaque marker for easy detection via X-ray.

Intended Use: The XSTAT-12 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. Indications for Use: XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT-12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT-12 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inquinal ligament; or tissues above the clavicle.

The XSTAT-12 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 38 minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. The minisponges expand only in length, not radially. Each minisponge absorbs approximately 3 mL of blood. Each minisponge contains a radiopaque marker for easy detection via X-ray. The XSTAT-12 dressing includes an applicator and plunger that facilitate delivery of the minisponges to external bleeding wounds. Individual applicators are filled with the STAT-12 minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, terminally sterilized by gamma radiation to a sterility assurance level of 10°. The inner pouches are then packaged inside a larger outer pouch, along with one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch. For the treatment of severe. life-threatening bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT-12 sponges are applied to the applicator. Once applied to the wound, the XSTAT-12 sponges absorb blood and expand, thereby packing the wound. All minisponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the minisponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every minisponge has been removed.

Intended Use: The XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. Indications for Use: XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.

The XSTAT 30 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 92 mini-sponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The compressed regenerated cellulose sponge is coated with chitosan. Upon contact with blood, the mini-sponges absorb blood and, if unencumbered, are capable of expanding to a pre-compressed height of 40-50 mm within approximately 20 seconds. A radiopaque marker is embedded into a circular surface of the mini-sponges to render each sponge detectable via X-ray. The XSTAT 30 dressing includes an applicator that facilitates delivery of the mini-sponges to external bleeding wounds. Three applicators filled with the XSTAT 30 dressing (i.e., mini-sponges) are packaged in a sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°. For the treatment of severe bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT 30 sponges are applied to the wound using the applicator. Once applied to the wound, the XSTAT 30 sponges absorb blood and expand, thereby packing the wound. All mini-sponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the mini-sponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every mini-sponge has been removed.

XSTAT is a hemostatic device for the control of bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents. XSTAT is a temporary device for use up to four (4) hours until surgical care is acquired. XSTAT is intended for use in the battlefield.

XSTAT consists of three sterile, syringe-style applicators containing compressed cellulose sponges with an absorbant animal-derived coating. The applicators facilitate fast delivery of the sponges into bleeding wounds. The black, telescoping handle is pulled away from the barrel of the applicator to prepare for sponge deployment. The tip of the applicator is placed into the wound track as close as possible to the source of bleeding before pushing the handle to deploy the sponges. Trained emergency responders may apply up to three applicators of sponges into junctional wounds in the groin or axilla as needed to completely pack the wound. Each applicator houses 92 non-absorbable, expandable sponges for a total of 276 sponges per device (see Figure 1). Each sponge absorbs 3 ml of blood and a single applicator is therefore capable of absorbing approximately 300 ml. The sponges rapidly expand in length (see Figure 2) upon contact with blood or fluid to fill the wound cavity and thereby provide a physical barrier and pressure that facilitate formation of a clot. Once hemostasis is achieved, a standard occlusive dressing is applied before transporting the patient to a medical facility where surgery is performed to definitively repair the wound. The sponges are intended for temporary use up to four hours until surgical care is acquired. All sponges must be removed from wounds manually and/or with forceps by a surgeon with the capability and equipment for achieving proximal and distal vascular control. For easy detection via x-ray, one face of each tablet contains radiopaque filaments in an "x" pattern (see Figure 2). To confirm removal of all sponges and any applicator tips, a radiograph is required prior to wound closure with imaging in more than one plane recommended.

The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.

A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.

The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.

The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.

The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of: - A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software. - NuQuest™ Nuclear Medicine Computer and related . software. The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software. The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software.

The Giotto Image X-ray Mammographic System is intended to provide filmscreen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.

The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto Image allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.