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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 clean the instrument/suction channel and accessories of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB7025DC
In Commercial Distribution

  • 14547410341345 ()
  • 04547410341348 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the suction valve cylinder, air/water valve cylinder, and instrument channel inlet of a FUJIFILM endoscope, as well as the water pump side connector of the J tube in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB11003DV
In Commercial Distribution

  • 14547410341338 ()
  • 04547410341331 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
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-530LS V2
In Commercial Distribution

  • 04547410341294 ()


  • 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.
FUJIFILM CORPORATION
EC-530HL V2
In Commercial Distribution

  • 04547410341287 ()


  • Flexible video colonoscope, reusable
This device is intended to be installed into the suction valve on the control portion of our ultrasonic endoscope in order to switch suck operation and balloon suck operation selectively. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-601
In Commercial Distribution

  • 04547410339437 ()
  • 24547410339431 ()


  • Endoscope suction valve, reusable
This product is a medical device that is attached to a FUJIFILM ultrasonic endoscope in order to jet air or water as well as to feed water into the balloon. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AW-601
In Commercial Distribution

  • 04547410339420 ()
  • 24547410339424 ()


  • Endoscope air/water valve, reusable
The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The DR-XD 1000 is not intended for mammography applications.
FUJIFILM CORPORATION
DR-XD 1000
In Commercial Distribution

  • 04547410339161 ()


  • Mobile basic diagnostic x-ray system, digital
This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure.
FUJIFILM CORPORATION
BL-7000
In Commercial Distribution

  • 04547410337730 ()


  • Endoscopic light source unit, line-powered
The VP-7000 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 and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
FUJIFILM CORPORATION
VP-7000
In Commercial Distribution

  • 04547410337419 ()


  • Endoscopic video image processing unit
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 v2
In Commercial Distribution

  • 04547410337402 ()
  • 14547410337409 ()


  • Flexible video gastroduodenoscope
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 v2
In Commercial Distribution

  • 04547410337396 ()
  • 14547410337393 ()


  • Flexible video colonoscope, 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 BPY-L HA USA E
In Commercial Distribution

  • 04547410336047 ()


  • Stationary mammographic x-ray system, digital
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 A E
In Commercial Distribution

  • 04547410335286 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2623J -N20-
In Commercial Distribution

  • 04547410334999 ()
  • 14547410334996 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2623J -N15-
In Commercial Distribution

  • 04547410334982 ()
  • 14547410334989 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N15-
In Commercial Distribution

  • 04547410334548 ()
  • 14547410334545 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -N10-
In Commercial Distribution

  • 04547410334531 ()
  • 14547410334538 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -B30-
In Commercial Distribution

  • 04547410334524 ()
  • 14547410334521 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DK2618J -B25-
In Commercial Distribution

  • 04547410334517 ()
  • 14547410334514 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TY-06D
In Commercial Distribution

  • 04547410332100 ()


  • Medical air low pressure hose
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TY-04D
In Commercial Distribution

  • 04547410332094 ()


  • Medical air low pressure hose
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
PB-30
In Commercial Distribution

  • 04547410332063 ()


  • Catheter/overtube balloon inflator, reusable
This product is the lamp unit used in combination with our light source in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
LMP-SD
In Commercial Distribution

  • 04547410331752 ()


  • Procedural cold light bulb
These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-30CR
In Commercial Distribution

  • 14547410331674 ()
  • 04547410331677 ()


  • Endoscope tissue removal cap, single-use
These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-29CR
In Commercial Distribution

  • 14547410331667 ()
  • 04547410331660 ()


  • Endoscope tissue removal cap, single-use
These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-28GR
In Commercial Distribution

  • 14547410331650 ()
  • 04547410331653 ()


  • Endoscope tissue removal cap, single-use
The Fujifilm Double Balloon Endoscopes are 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.
FUJIFILM CORPORATION
EN-530T
In Commercial Distribution

  • 04547410331646 ()
  • 14547410331643 ()


  • 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-530CT
In Commercial Distribution

  • 04547410331639 ()
  • 14547410331636 ()


  • Flexible video gastroduodenoscope
This product is intended to confirm airtight of the endoscope.
FUJIFILM CORPORATION
LT-7F
In Commercial Distribution

  • 04547410331615 ()


  • Invasive medical device leak tester, mechanical
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
CT-11G
In Commercial Distribution

  • 04547410331608 ()
  • 14547410331605 ()


  • Medical air low pressure hose
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