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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S300A
In Commercial Distribution

  • 06971381252392 ()


  • Endoscopic video image processing unit
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section.This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1C-P
Not in Commercial Distribution

  • 16971381252382 ()
  • 06971381252385 ()


  • Flexible video bronchoscope, single-use
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1A-B
In Commercial Distribution

  • 16971381252337 ()
  • 06971381252330 ()


  • Flexible video bronchoscope, single-use
The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SL102
In Commercial Distribution

  • 06971381251364 ()


  • Laparoscopic insufflator
The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SL101
In Commercial Distribution

  • 06971381251357 ()


  • Laparoscopic insufflator
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. Near-Infrared LED Light Source is intended to be used for providing white light and near-infrared light illumination for optical observation or rear camera system of electronic endoscope during endoscopy and endoscopic surgery, not the illumination provided for the human eye to observe the optical endoscope.The product is composed of a control unit and a power cable, without light guide.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
LSIR330
In Commercial Distribution

  • 06971381250947 ()


  • Endoscopic light source unit, line-powered
The product is composed of the endoscopic image processor, the foot switch, the power cord and the video cables. The foot switch and the video cables are the optional accessories. This endoscopic image processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S100D
In Commercial Distribution

  • 06971381250503 ()


  • Endoscopic video image processing unit
The product is composed of a main equipment, a light guide cable and a power cable.The purpose of this product is to provide illumination for optical observation or electronic endoscope rear camera system, not for human eye observation optical endoscope lighting.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
ES-LS110D
In Commercial Distribution

  • 06971381250114 ()


  • Endoscopic light source unit, line-powered
The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100E
In Commercial Distribution

  • 06971381250053 ()


  • Endoscopic video image processing unit
The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100D
In Commercial Distribution

  • 06971381250046 ()


  • Endoscopic video image processing unit
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