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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
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