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Disposable Biopsy Refill Needle is intended for soft tissue core biopsy from liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The disposable biopsy refill needle (hereinafter referred to as refill needle) is divided into A and B in accordance with different configuration. A contains biopsy refill needle. B contains biopsy refill needle and coaxial biopsy needle. The disposable biopsy refill needle consists of stylet housing, stylet, canular housing, fixation parts, canula and protecting sheath. It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, pale blue= 12G). The needles have a protecting sheath. The Disposable Biopsy Refill Needle is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of Disposable Biopsy Refill Needle is typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The Disposable Semi Automatic Biopsy Instrument is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures

The disposable semi automatic biopsy instrument (hereinafter referred to as biopsy instrument) is divided into A and B in accordance with different configuration. A contains semi automatic biopsy needle. B contains semi automatic biopsy needle and coaxial biopsy needle. The disposable semi automatic biopsy instrument consists of cannula, stylet, protecting sheath and mechanical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping (option), stylet housing and protecting sheath. It is available in several gauge sizes and lengths. Both the A and B of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath. The disposable semi automatic biopsy instrument is loaded a semi automatic biopsy needle that is visible in ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. Centimeter markings on the cannula surface permits an easy identification of the insertion depth with the maximum safety for the patient.During use, the position of the device is monitored using technique. The inner stylet which has a triple face ultra-sharp tip to penetrate easily also into fibrous tissues is equipped with a slot/ groove (a 19mm specimen notch) to collect a biopsy specimen. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of disposable semi automatic biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

Disposable Coaxial Biopsy Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone.

The disposable coaxial biopsy needle consists of canular housing, canula, marker, stylet with sharping, stylet without sharping, stylet housing and protecting sheath. It is available in several gauge sizes and lengths. The disposable coaxial biopsy needle (hereinafter referred to as coaxial biopsy needle) is divided into 11G、13G、15G、17G、19G in accordance with the outer diameter of canula and 70mm、78mm、100mm、130mm、138mm、170mm、170mm and 178mm in accordance with the length of canula. The materials used for construction of disposable coaxial biopsy needle are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. The disposable coaxial biopsy needle can be used with the matching biopsy needle under the guidance of medical imaging, as a channel for other biopsy needles to enter the body and obtain biopsy samples through negative pressure or cutting for clinical diagnosis or treatment. In clinical practice, doctors sometimes repeatedly puncture the target site for biopsy. At this time, the coaxial needle is configured, which provides a channel that the device can take multiple samples at the target site. That avoids repeated puncture and injury on the patient's skin surface. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.

The disposable automatic core biopsy instrument is divided into QZDA and QZDB in accordance with different configuration. QZDA contains automatic core biopsy instrument. QZDB contains automatic core biopsy instrument and coaxial biopsv needle. The automatic core biopsy instrument consists of canula, stylet, protecting sheath and mechnical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet, stylet housing and protecting sheath. The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. Both the QZDA and QZDB of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath. The disposable automatic core biopsy instrument is a spring-loaded automatic biopsy needle that is visible in CT (computed tomography) and ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of disposable automatic core biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.