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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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FUJIFILM - 04547410331127

This product is the lamp unit used in combination with our processor in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
LMP-001
In Commercial Distribution

  • 04547410331127 ()


  • Procedural cold light bulb

FUJIFILM - 04547410331103

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

FUJIFILM - 04547410331073

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

FUJIFILM - 04547410331066

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

FUJIFILM - 04547410331042

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

FUJIFILM - 04547410331035

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

FUJIFILM - 04547410331028

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

FUJIFILM - 04547410331011

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

FUJIFILM - 04547410331004

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

FUJIFILM - 04547410330991

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

FUJIFILM - 04547410330977

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
ES-450WE5
In Commercial Distribution

  • 04547410330977 ()
  • 14547410330974 ()


  • Flexible video sigmoidoscope, reusable

FUJIFILM - 04547410330960

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-450T5
In Commercial Distribution

  • 04547410330960 ()
  • 14547410330967 ()


  • Flexible video enteroscope

FUJIFILM - 04547410330953

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

FUJIFILM - 04547410330946

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-450LP5
In Commercial Distribution

  • 04547410330946 ()
  • 14547410330943 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410330939

The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagonosis, and endoscopic treatment.
FUJIFILM CORPORATION
EC-450BI5
In Commercial Distribution

  • 04547410330939 ()
  • 14547410330936 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410330922

This device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.
FUJIFILM CORPORATION
EB-470P
In Commercial Distribution

  • 04547410330922 ()
  • 14547410330929 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410330915

The Fujifilm Duodenoscope Model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
ED-530XT
In Commercial Distribution

  • 04547410330915 ()
  • 14547410330912 ()


  • Flexible video duodenoscope, reusable

FUJIFILM - 04547410330663

This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes.
FUJIFILM CORPORATION
DC-07D
In Commercial Distribution

  • 04547410330663 ()
  • 84547410330669 ()
  • 24547410330667 ()


  • Flexible video duodenoscope, reusable

FUJIFILM - 04547410330243

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

FUJIFILM - 04547410330236

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

FUJIFILM - 04547410330229

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

FUJIFILM - 04547410330212

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

FUJIFILM - 04547410330205

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

FUJIFILM - 04547410330199

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

FUJIFILM - 04547410330182

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

FUJIFILM - 04547410330175

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

FUJIFILM - 04547410330168

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

FUJIFILM - 04547410330151

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

FDR-2000BPY - 04547410327342

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

Protection Cover - 04547410324884

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

FUJIFILM - 04547410324280

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

FUJIFILM - 04547410324037

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

FUJIFILM - 04547410324006

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

FUJIFILM - 04547410323917

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

FUJIFILM - 04547410323863

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

FUJIFILM - 04547410323856

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

DR-ID 1300MP - 04547410322934

A device supplying power to the flat panel sensor and connecting between the flat panel sensor and image processing unit.
FUJIFILM CORPORATION
DR-ID 1300 MP E
In Commercial Distribution

  • 04547410322934 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 1305SE - 04547410322927

The DR-ID 1305SE incorporates a GOS indirect panel.
FUJIFILM CORPORATION
DR-ID 1305 SE E
In Commercial Distribution

  • 04547410322927 ()

  • 567.4x1339.8x50mm


  • Stationary basic diagnostic x-ray system, digital

Power box - 04547410319385

A device supplying power to the flat panel sensor and connecting between the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 1200 PB E
In Commercial Distribution

  • 04547410319385 ()


  • Diagnostic x-ray digital imaging conversion system

FUJIFILM - 04547410313338

This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck air in the body cavity as well as to feed water into the balloon. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-604
In Commercial Distribution

  • 24547410313332 ()
  • 04547410313338 ()


  • Endoscope suction valve, reusable
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