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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 - 04547410331486

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

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 - 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 - 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

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

FUJIFILM - 04547410313321

This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to jet air or water as well as to dischange water from the balloon. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AW-602
In Commercial Distribution

  • 24547410313325 ()
  • 04547410313321 ()


  • Endoscope air/water valve, reusable

FUJIFILM - 04547410313314

This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck mucus or air in the body cavity. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-605
In Commercial Distribution

  • 24547410313318 ()
  • 04547410313314 ()


  • Endoscope suction valve, reusable

FUJIFILM - 04547410313307

This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to jet air or water. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AW-603
In Commercial Distribution

  • 24547410313301 ()
  • 04547410313307 ()


  • Endoscope air/water valve, reusable

FDR D-EVO Mobile Compo - 04547410308402

DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD.
FUJIFILM CORPORATION
DR-ID 800 IU DV2 E
In Commercial Distribution

  • 04547410308402 ()

  • 169×326×230mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410307061

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W E
In Commercial Distribution

  • 04547410307061 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410306651

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC E
In Commercial Distribution

  • 04547410306651 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MP - 04547410306644

Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 900 MP E
In Commercial Distribution

  • 04547410306644 ()

  • 464.5 x 516.7 x 18 mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 911SE - 04547410306637

The DR-ID 911SE is incorporate a CsI indirect panel. Wireless communication mode or wired communication mode can be used.
FUJIFILM CORPORATION
DR-ID 911 SE W E
In Commercial Distribution

  • 04547410306637 ()

  • 464.5 x 516.7 x 18 mm


  • Stationary basic diagnostic x-ray system, digital

D-EVO Advanced C43A - 04547410306613

The DR-ID 911SE is incorporate a CsI indirect panel. Wireless communication mode or wired communication mode can be used.
FUJIFILM CORPORATION
DR-ID 911 SE E
In Commercial Distribution

  • 04547410306613 ()

  • 18.2 x 20.3 x 0.70


  • Stationary basic diagnostic x-ray system, digital

D-EVO II C24 - 04547410305067

The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE E
In Commercial Distribution

  • 04547410305067 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system

ASPIRE Cristalle - 04547410297546

The Fujifilm Digital Mammography Systems, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FUJIFILM CORPORATION
DR 3500 W 24X30 USA + E
In Commercial Distribution

  • 04547410297546 ()


  • Stationary mammographic x-ray system, digital

FUJIFILM - 04547410297362

This product is exclusively used for manual cleaning and manual disinfection of a FUJIFILM ultrasonic endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-608
In Commercial Distribution

  • 24547410297366 ()
  • 04547410297362 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410297355

This product is exclusively used for manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-610
In Commercial Distribution

  • 24547410297359 ()
  • 04547410297355 ()


  • Luminal device flushing tubing set, reusable

FDR D-EVO II Battery Charger - 04547410289077

A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410289077 ()


  • Diagnostic x-ray digital imaging conversion system

Docking stand - 04547410289039

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 DS E
In Commercial Distribution

  • 04547410289039 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 1200MC - 04547410288995

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 1200 MC SOFT E
In Commercial Distribution

  • 04547410288995 ()


  • Diagnostic x-ray digital imaging conversion system

D-EVO II C35 - 04547410288902

The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1211 SE E
In Commercial Distribution

  • 04547410288902 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system

D-EVO II G35 - 04547410288803

The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1201 SE E
In Commercial Distribution

  • 04547410288803 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system

FCR CARBON X - 04547410265903

The FCR CARBON X (CR-IR 357) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 357
In Commercial Distribution

  • 04547410265903 ()


  • Computed radiography digital imaging scanner

DR-ID 670MC - 04547410261189

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 670 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410261189 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 670 - 04547410261172

Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 670 MP A E
In Commercial Distribution

  • 04547410261172 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 613SE - 04547410257007

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
DR-ID 613 SE WIRED W E
In Commercial Distribution

  • 04547410257007 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 613SE - 04547410256994

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
DR-ID 613 SE W E
In Commercial Distribution

  • 04547410256994 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 612SE - 04547410256987

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
DR-ID 612 SE WIRED W E
In Commercial Distribution

  • 04547410256987 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 612SE - 04547410256970

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
DR-ID 612 SE W E
In Commercial Distribution

  • 04547410256970 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
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