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Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery. Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed. The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.

Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, gentourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: orthopedics.

The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswtich, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswtich, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear.

The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector. ·Laser must operate at a wavelength between 532 and 1064 nm. * Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. - · Laser must have a numerical aperture of 0.35 or less. · Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector. Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected. During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.

The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease. The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.

TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas. The proposed device has 2 models depending on the diameter of the needle.

Qitexio Luer Lock Syringes are manual devices used to inject fluids into the body. They are also used for delivery of Lipiodol (Ethiodized Oil) Injection.

Medex, a subsidiary of Guerbet Group, designed and manufactures the Qitexio® Luer Lock Syringe, a disposable, handheld syringe available in 3 different volumes (1, 3 and 20 mL). Oitexio® Syringes are standard syringes which are verified to endure the potentially damaging chemical effects of Lipiodol® (Ethiodized Oil), an oil-based contrast media manufactured by Guerbet. Qitexio® Luer Lock Syringes are manual devices used to inject fluids into the body. Qitexio® Syringes are also used for delivery of Lipiodol® (Ethiodized Oil) Injection. They are single-use devices, sterilized by gamma radiation. Standard five-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting movable plunger, O-Ring, rotative finger flange, and backstop. Fitting offered with male luer lock.

Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

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Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Nautilus Delta™ system consists of the following elements: single use sterile ECG extension cable (also known as Nautilus Electrical Adaptor also known as NautilusE), non-sterile ECG cable, patient module (ECG data acquisition and processing and integrated remote control), and mobile medical application running on any mobile platform which complies with the minimum requirements. Nautilus Delta™ provides real-time catheter tip location information by using the patient's cardiac electrical activity (ECG). This information can be used to position any central venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of central venous catheters from the vascular access point towards the CAJ by computing and displaying a navigation signal. Nautilus Delta also displays on its graphical user interface the surface (skin) ECG signal, a marker identifying the R-peak, and the patient's heart rate. In order to obtain intravascular ECG information at the tip (distal end) of a catheter, a stylet or a guidewire inserted in the catheter can be connected to Nautilus Delta patient module via the sterile Nautilus Delta ECG extension cable. Nautilus Delta and NautilusE do not have any direct or indirect contact with the patient.

The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.

The QFlow 500™ Titanium Bolt Quad Lumen Kit is used to achieve cranial access and to introduce and secure up to four sensors in place for intracranial monitoring. The kit contains a cranial bolt, drill bit, scalpel, sensor introducer with stylet, Touhy Borst fittings and connectors. The cranial bolt contains four lumens with its primary materials being titanium, polyphenylsulfone, polyvinyl chloride and polycarbonate. The primary materials of the sensor introducer are polyether block amide and polycarbonate. The primary materials of the other components in the kit are stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyphenylsulfone, polyvinyl chloride and polycarbonate.

The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECG module and cable, laptop running Sapiens™ TLS software, label printer (optional), and remote control (optional). A stylet or a guidewire inserted in a central venous catheter can be connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptor establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. A different ECG signal measurement method - the column of saline method - can be used by connecting the Sapiens™ TLS Electrical Adaptor to the Arrow- Johans Adaptor, by connecting the Arrow-Johans Adaptor to any central venous catheter and by injecting saline solution into the catheter lumen through the Arrow-Johans Adaptor, thus establishing electrical conductivity to the distal tip of the catheter. When the central venous catheter or its associated stylet or guidewire is connected to Sapiens™ TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascular electrograms acquired at the location of the distal tip of the catheter. The waveforms provided by Sapiens™ TLS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional label printer to document the catheter tip location for the patient's file.