Search Results

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The device models are Y-09-40, Y-09-50, Y-10-40, Y-10-50, Y-11-40, Y-11-50, Y-12-40, and Y-12-50. The device is composed of access sheath and dilator. The access sheath consists of sheath tube and connector. The dilator consists of dilator tube and dilator base. Single-use Ureteral Access Sheath is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.

The Koala Intrauterine Pressure Catheter is a disposable, sterile, single patient use intrauterine pressure monitoring catheter, designed for measurement of intrauterine contraction pressures. The catheter is designed with a pressure-sensing membrane cavity at the tip (mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. The Koala Intrauterine Pressure Catheters utilizes a reusable cable with a reusable pressure transducer which is connected at the other end of the device. The sensor, located on the tip of the catheter is a 360° sensor that registers pressure in all directions. The tip is made of soft, malleable urethane. There are no electronics in the catheter. Clinicians can disconnect the catheter while it is in the uterus and zero the monitor while the transducer is exposed to atmospheric pressure, providing a true zero reading. The Koala Intrauterine Pressure Catheter has two different, clear lumens, one for the amnioinfusion, to confirm proper placement via amniotic fluid flashback, and another channel for sensor-charging. The amnioinfusion port has a hydrophobic and a tethered replacement cap.

The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.

For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma using the VITROS 5600 Integrated System. The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection. The VITROS Syphilis test is not intended for blood and tissue donor screening.

The VITROS Immunodiagnostic Products Syphilis test is performed using the VITROS Immunodiagnostic Products Syphilis Reagent Pack and VITROS Immunodiagnostic Products Syphilis Calibrator on the VITROS 5600 Integrated System. An immunometric technique is used; this involves a two-stage reaction. In the first stage antibodies to Syphilis TP specific antigens present in the sample bind with biotinylated recombinant Syphilis TP antigens immobilized on streptavidin coated wells. Unbound sample is removed by washing. In the second stage conjugate reagent containing horseradish peroxidase (HRP)-labeled recombinant Syphilis TP antigens is added. The conjugate binds specifically to any antibody to Syphilis TP specific antigens captured on the well in the first stage. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system.

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI). Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression. Therm-X (Therm-X Home and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT. Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time. Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only. Therm-X (Therm-X Home and Therm-X AT) is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature, and compression settings. Therm-X AT and Therm-X Home models provide an optional password protection feature that allows for a user to use only stored cycles, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first. The Therm-X device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature). Therm-X (Therm-X Home and Therm-X AT) is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

The Ureterorenoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.

The Ureterorenoscope System consists of a single-use Ureterorenoscope(HU30S) to provide illumination and intuitive images in endoscopy and endoscopic surgery within urinary tract and interior of the kidney and serves as a guide to diagnosis and management with accessories and an image processor, previous clearly by K231118, for clinical image processing. The single-use Ureterorenoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Ureterorenoscope and outputs video signals to a display.

For in vitro diagnostic use only. For the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (heparin and EDTA) using the VITROS 5600 Integrated System to aid in the early detection of pregnancy.

The VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (test) is performed using the VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG II Calibrators on the VITROS 5600 Integrated System. An immunometric immunoassay technique is used, which involves the reaction of human chorionic gonadotropin (hCG) present in the sample with a microwell coated with biotinylated Antibody (mouse monoclonal anti-ß-hCG) bound to streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (mouse monoclonal anti-ß-hCG). Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of hCG present in the sample. VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack contains: 1 reagent pack containing: - 100 coated wells (antibody, mouse monoclonal anti-ß-hCG, binds >600 mIU hCG/well) - 14.4 mL assay reagent (buffer containing mouse serum, bovine serum albumin, bovine gamma globulin and . antimicrobial agent) - 19.2 mL conjugate reagent (HRP-mouse monoclonal anti-β-hCG, binds ≥4005 mIU hCG/mL) in buffer with ● bovine serum albumin and antimicrobial agent. VITROS Total ß-hCG II Calibrators contains: - 3 sets of VITROS Total ß-hCG II Calibrators 1, 2 and 3, (freeze-dried, recombinant hCG in human plasma with antimicrobial agent, reconstitution volume 1.0 mL), nominal values 0; 3,000; 14,000 mIUmL (U/L) - 24 calibrator bar code labels (8 for each calibrator)

The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope. The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.

+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems. Medical Facilities use their clinical protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility < clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives. lt is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions. +ACG is not intended to be used for secondary monitoring. +ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action. +ACG only works with Talis EMR Products.

Talis EMR software is an Electronic Medical Record intended to support patient care documentation compliant with patient care record and billing requirements. Talis EMR leverages a non-device MDDS to acquire, transmit, store, and display electronic patient information available from multiple electronic sources including other EMRs and medical devices. Talis EMR provides no clinical recommendations, performs no assessment of patient conditions, and uses no proprietary algorithms. Display or access to patient data is not intended to influence the judgement of the healthcare professional user. Talis EMR software functions are either non-device software functions or software functions for which FDA has determined to exercise enforcement discretion. +ACG software is an alarm notification system which may be configured to notify health care professionals when alarm or advisory conditions are identified based on patient data matching the Medical Facility defined alarm or advisory condition criteria. +ACG alarm/advisory notifications are limited to alarm or advisory conditions defined by the Medical Facility. Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives. +ACG software only works with Talis EMR software.

The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.