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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This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TY-04D
In Commercial Distribution

  • 04547410332094 ()


  • Medical air low pressure hose
The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.
FUJIFILM CORPORATION
EN-530T
In Commercial Distribution

  • 04547410331646 ()
  • 14547410331643 ()


  • Flexible video enteroscope
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-530CT
In Commercial Distribution

  • 04547410331639 ()
  • 14547410331636 ()


  • Flexible video gastroduodenoscope
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
FUJIFILM CORPORATION
CT-11G
In Commercial Distribution

  • 04547410331608 ()
  • 14547410331605 ()


  • Medical air low pressure hose
This product is used for cleaning the contaminated forceps channel by passing together with water, detergent etc. after examined with our endoscopes.
FUJIFILM CORPORATION
WB4325DS
In Commercial Distribution

  • 84547410331482 ()
  • 04547410331486 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
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-450CT5
In Commercial Distribution

  • 04547410330991 ()
  • 14547410330998 ()


  • Flexible video gastroduodenoscope
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