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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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These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TS-12140
In Commercial Distribution

  • 04547410331493 ()
  • 24547410331497 ()


  • Endoscopic overtube, single-use
This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WT-4
In Commercial Distribution

  • 04547410331172 ()


  • Surgical irrigation pump
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air and water through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
FUJIFILM CORPORATION
XL-4450
In Commercial Distribution

  • 04547410331103 ()


  • Endoscopic light source unit, line-powered
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-600WL
In Commercial Distribution

  • 04547410331073 ()
  • 14547410331070 ()


  • Flexible video colonoscope, reusable
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-600WR
In Commercial Distribution

  • 04547410331066 ()
  • 14547410331063 ()


  • Flexible video gastroduodenoscope
The device is intended for the visualization of upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
FUJIFILM CORPORATION
EG-530N
In Commercial Distribution

  • 04547410331042 ()
  • 14547410331049 ()


  • Flexible video gastroduodenoscope
The device is intended for the visualization of upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.
FUJIFILM CORPORATION
EG-530NP
In Commercial Distribution

  • 04547410331035 ()
  • 14547410331032 ()


  • Flexible video gastroduodenoscope
This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-530WR
In Commercial Distribution

  • 04547410331028 ()
  • 14547410331025 ()


  • Flexible video gastroduodenoscope
This product is a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb at medical facilities under management of physicians.
FUJIFILM CORPORATION
EG-450PE5
In Commercial Distribution

  • 04547410331011 ()
  • 14547410331018 ()


  • Flexible video gastroduodenoscope
This product is a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb at medical facilities under management of physicians.
FUJIFILM CORPORATION
EG-450D5
In Commercial Distribution

  • 04547410331004 ()
  • 14547410331001 ()


  • Flexible video gastroduodenoscope
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