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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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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
This device is intended for the visualization of the upper and lower digestive tracts, specially for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum.
FUJIFILM CORPORATION
EN-450P5/20
In Commercial Distribution

  • 04547410330953 ()
  • 14547410330950 ()


  • Flexible video enteroscope
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 VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.
FUJIFILM CORPORATION
VP-4440HD
In Commercial Distribution

  • 04547410330175 ()


  • Endoscopic video image processing unit
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
The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates.
FUJIFILM CORPORATION
POSITIONER KIT BPSY HA USA E
In Commercial Distribution

  • 04547410327342 ()


  • Stationary mammographic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
F898Y200123
In Commercial Distribution

  • 04547410324884 ()


  • Stationary basic diagnostic x-ray system, digital
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
This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-510/A
In Commercial Distribution

  • 24547410324031 ()
  • 04547410324037 ()


  • Luminal device flushing tubing set, reusable
This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB5021FW2
In Commercial Distribution

  • 04547410324006 ()
  • 34547410324007 ()
  • 44547410324004 ()


  • Surgical instrument/endoscope cleaning utensil, reusable
This product is a medical Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians.
FUJIFILM CORPORATION
EC-450DL5
In Commercial Distribution

  • 04547410323917 ()
  • 14547410323914 ()


  • Flexible video colonoscope, reusable
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. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.
FUJIFILM CORPORATION
EC-530LS2
In Commercial Distribution

  • 04547410323863 ()
  • 14547410323860 ()


  • Flexible video colonoscope, reusable
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. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.
FUJIFILM CORPORATION
EC-530HL2
In Commercial Distribution

  • 04547410323856 ()
  • 14547410323853 ()


  • Flexible video colonoscope, reusable
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