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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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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
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 -B20-
In Commercial Distribution

  • 04547410334500 ()
  • 14547410334507 ()


  • 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 -B15-
In Commercial Distribution

  • 04547410334494 ()
  • 14547410334491 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
This product is intended to seal the acoustic coupling medium when used with Fujinon/Fujifilm ultrasonic endoscope EB-530US. Do not use this product for any other purpose.
FUJIFILM CORPORATION
B20BU
In Commercial Distribution

  • 04547410333435 ()
  • 14547410333432 ()


  • Bronchial balloon catheter
The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 FV652A
In Commercial Distribution

  • 04547410332353 ()


  • General-purpose ultrasound imaging system
The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 PLATINUM FV651A
In Commercial Distribution

  • 04547410332346 ()


  • General-purpose ultrasound imaging system
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
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 used for cleaning the contaminated forceps channel by passing together with water, detergent etc. after examined with our endoscopes.
FUJIFILM CORPORATION
WB3225DS
In Commercial Distribution

  • 84547410331369 ()
  • 04547410331363 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WT-4
In Commercial Distribution

  • 04547410331172 ()


  • Surgical irrigation pump
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-002
In Commercial Distribution

  • 04547410331134 ()


  • Procedural cold light bulb
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
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
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
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
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