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Sterile and Non-Sterile Ultrasonic Coupling Agent are ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to cound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The subject device, Sterile and Non-Sterile Ultrasonic Coupling Agent, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the Ultrasonic Coupling Agent is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.

The Non-sterile Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The proposed device, Non-Sterile Ultrasound Transmission Gels, are non- irritating, non sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to improve the acoustic transmission of sound waves to create the ultrasound image. The subject device is available in the below sizes: 20g/bag,250ml/bottle, 1000ml/bottle,2000ml/bottle,5000ml/bottle,250g/bottle,1000g/bottle,2000 g/bottle,5000g/bottle.

Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.

The proposed device, Sterile and Non-Sterile Ultrasound Gels, are non- irritating, nonsensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.

Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.

The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image. The subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

Ultrast Gel is an in vivo biocompatible sterile sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. Ultrast Gel is used to couple sound waves between the patient and medical imaging electronic transducers during intracavitary medical diagnostic ultraging procedures, transcutaneous ultrasound image guided biopsy and aspiration, intracavity ultrasound imaging, and gel infusion sonography. Ultrast Gel is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required. ULTRAST Gel is available by prescription only for use by healthcare providers trained in performing the indicated procedure.

The Ultrast Gel device, manufactured for Ultrast, Inc. is a phase changing hydrogel ultrasound coupling agent comprised of hydroxy-propylcellulose, sodium chloride, sodium citrate, and water. HCl may be added to adjust pH if necessary. The gel is viscous at room temperature, but subsequently liquefies as its temperature rises and reaches body temperature. In addition to general lubricating/coupling properties, the gel may be instilled in the uterine cavity through a standard intrauterine insemination (IUI) catheter to provide excellent ultrasonographic visualizations, after which point it liquifies and passes out of the uterine cavity. The gel is contained in a single use 5cc capped syringe enclosed in a peel pouch to maintain sterility.

The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

The proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.

UltraPhonic® Scanning Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.

Ultra/Phonic® Scanning Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.

Ultra Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.

Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles. Major characteristics include: - Non-sensitizing, non-irritating - Water soluble, non-staining, and easily cleanable - Does not contain oil or fatty matter - Does not damage the probe - pH level is 6.25 ± 0.25 @ 25°C - Resists thinning and decomposition when exposed to perspiration and body heat - Sheer thinning gel is easy to apply, but doesn't run or drip - High viscosity allows for thick application, adapting to contours and hair to minimize interference

Other-Sonic™ Transmission Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.

Other-Sonic™ Transmission Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles.