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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 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
GW-100
In Commercial Distribution

  • 04547410331592 ()


  • Gastrointestinal endoscopic insufflator
This product is intended to be used in combination with the FUJIFILM endoscopic CO2 regulator GW-100, of which the Operation Manual lists the water tank WT-04G as a consumable supply in the “Main Specifications” section. Do not use this product for any other purposes.
FUJIFILM CORPORATION
WT-04G
In Commercial Distribution

  • 04547410331585 ()


  • Surgical irrigation pump
This product is a balloon for containing the ultrasonic transmitting medium to be used in combination with Fujinon/Fujifilm ultrasonic endoscope EG-530UT in a medical facility under the supervision of a physician. Do not use the product for any other purpose. This product is not intended to be used for children or infants.
FUJIFILM CORPORATION
B20UT
In Commercial Distribution

  • 04547410331578 ()
  • 84547410331574 ()
  • 14547410331575 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
This product is a balloon for containing the ultrasonic transmitting medium to be used in combination with Fujinon/Fujifilm ultrasonic endoscope EG-530UR in a medical facility under the supervision of a physician. Do not use the product for any other purpose. This product is not intended to be used for children or infants.
FUJIFILM CORPORATION
B20UR
In Commercial Distribution

  • 04547410331561 ()
  • 84547410331567 ()
  • 14547410331568 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
This product is the suction button used in combination with our endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-500/G
In Commercial Distribution

  • 04547410331530 ()
  • 24547410331534 ()


  • Endoscope suction valve, reusable
This product is the air/water button used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AW-500
In Commercial Distribution

  • 04547410331523 ()
  • 24547410331527 ()


  • Endoscope air/water valve, reusable
These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TS-13140
In Commercial Distribution

  • 04547410331516 ()
  • 24547410331510 ()


  • Endoscopic overtube, single-use
This product is used in combination with a FUJINON/FUJIFILM Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. Never use this product for any other purposes. This product is not intended for use for any child or baby.
FUJIFILM CORPORATION
TS-13101
In Commercial Distribution

  • 04547410331509 ()
  • 24547410331503 ()


  • Endoscopic overtube, single-use
This product is designed to attach a rubber band for fixing a balloon attached to a double-balloon endoscope at medical facilities under management of physiciants. Never use this product for any other purpose. Do not use this product to attach a balloon to the endoscope.
FUJIFILM CORPORATION
ST-10
In Commercial Distribution

  • 04547410228090 ()


  • Endoscope balloon positioner, reusable
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 E
In Commercial Distribution

  • 04547410225587 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic 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
DR-ID 613 SE E
In Commercial Distribution

  • 04547410225570 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital
The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 363
In Commercial Distribution

  • 04547410220667 ()


  • Computed radiography digital imaging scanner
The FUJI Computed Radiography System FCR XG 5000 Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 362
In Commercial Distribution

  • 04547410220629 ()


  • Computed radiography digital imaging scanner
The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device.
FUJIFILM CORPORATION
CR-IR 363
In Commercial Distribution

  • 04547410220575 ()


  • Computed radiography digital imaging scanner
Before moving the vehicle, be sure to turn off the FCR PRIMA T and insert the dummy cassette.
FUJIFILM CORPORATION
IR DUMMY CASSETTE FOR MBL E
In Commercial Distribution

  • 04547410215373 ()


  • Computed radiography digital imaging scanner
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-500BU
In Commercial Distribution

  • 04547410104349 ()
  • 14547410104346 ()


  • Flexible ultrasound bronchoscope
This product is intended to assist in the manual cleaning of accessible channels found in certain Fujinon/Fujifilm endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB2212FW2
In Commercial Distribution

  • 04547410097603 ()
  • 34547410097604 ()
  • 44547410097601 ()


  • Flexible video bronchoscope, reusable
The suction button of our endoscope is installed, and the body fluid and blood, etc. are sucked from the inside of the body. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-500B/D
In Commercial Distribution

  • 14547410093299 ()
  • 04547410093292 ()


  • Flexible video bronchoscope, reusable
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-500C
In Commercial Distribution

  • 04547410093285 ()
  • 24547410093289 ()


  • Flexible video bronchoscope, reusable
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1283 SE FF E
In Commercial Distribution

  • 04547410549287 ()


  • Diagnostic x-ray digital imaging conversion system
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