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 device is 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. Never use this product for any other purposes.
FUJIFILM CORPORATION
EN-580T
In Commercial Distribution

  • 04547410330243 ()
  • 14547410330240 ()


  • 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-530D
In Commercial Distribution

  • 04547410330236 ()
  • 14547410330233 ()


  • Flexible video gastroduodenoscope
The FUJIFILM Endoscope Models EC-600LS 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-600LS
In Commercial Distribution

  • 04547410330229 ()
  • 14547410330226 ()


  • Flexible video colonoscope, reusable
The FUJIFILM Endoscope Models EC-600HL 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-600HL
In Commercial Distribution

  • 04547410330212 ()
  • 14547410330219 ()


  • Flexible video colonoscope, reusable
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-530UR2
In Commercial Distribution

  • 04547410330205 ()
  • 14547410330202 ()


  • Flexible ultrasound gastroduodenoscope
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UT2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-530UT2
In Commercial Distribution

  • 04547410330199 ()
  • 14547410330196 ()


  • Flexible ultrasound gastroduodenoscope
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
FUJIFILM CORPORATION
EB-530US
In Commercial Distribution

  • 04547410330182 ()
  • 14547410330189 ()


  • Flexible ultrasound bronchoscope
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-530H
In Commercial Distribution

  • 04547410330168 ()
  • 14547410330165 ()


  • Flexible video bronchoscope, reusable
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree.
FUJIFILM CORPORATION
EB-530T
In Commercial Distribution

  • 04547410330151 ()
  • 14547410330158 ()


  • Flexible video bronchoscope, reusable
This product is the tube kit used in combination with the compatible balloon controller in medical facilities . Do not use this product for any other purpose The product consists of a tube for connection to the endoscope and over-tube and balloon controller, and a filter. This product is supplied non-sterile. Also, The filter is a single patient use item. Prepare a new filter before use.
FUJIFILM CORPORATION
TY-500D
In Commercial Distribution

  • 04547410324280 ()


  • Medical air low pressure hose
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