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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 - 04547410395136

These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during an examination of the digestive tract.
FUJIFILM CORPORATION
DH-35GZ
In Commercial Distribution

  • 04547410395136 ()
  • 14547410395133 ()


  • Endoscope tissue removal cap, single-use

FUJIFILM - 04547410395105

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-33GR
In Commercial Distribution

  • 04547410395105 ()
  • 14547410395102 ()


  • Endoscope tissue removal cap, single-use

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard

FUJIFILM - 04547410388992

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard

FDR ES C35 - 04547410361360

The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1273 SE E
In Commercial Distribution

  • 04547410361360 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

FDR ES G43 - 04547410361353

The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1272 SE E
In Commercial Distribution

  • 04547410361353 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410358698

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-760ZP-V/L
In Commercial Distribution

  • 14547410358695 ()
  • 04547410358698 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410358681

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-760R-V/L
In Commercial Distribution

  • 14547410358688 ()
  • 04547410358681 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410358674

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-760Z
In Commercial Distribution

  • 14547410358671 ()
  • 04547410358674 ()


  • Flexible video gastroduodenoscope

FUJIFILM - 04547410358667

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-760R
In Commercial Distribution

  • 04547410358667 ()
  • 14547410358664 ()


  • Flexible video gastroduodenoscope

FDR ES Battery Pack - 04547410355420

A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1270 SE BATTERY E
In Commercial Distribution

  • 04547410355420 ()


  • Stationary basic diagnostic x-ray system, digital

FDR ES C24 - 04547410355406

The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1275 SE E
In Commercial Distribution

  • 04547410355406 ()

  • 328x268x15mm


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410349078

FUJIFILM Endoscope Model EG-580UR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-580UR
In Commercial Distribution

  • 14547410349075 ()
  • 04547410349078 ()


  • Flexible ultrasound gastroduodenoscope

FUJIFILM - 04547410349061

FUJIFILM Endoscope Model EG-580UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-580UT
In Commercial Distribution

  • 14547410349068 ()
  • 04547410349061 ()


  • Flexible ultrasound gastroduodenoscope

CR-IR 392 - 04547410343816

The CR-IR 392 is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410343816 ()


  • Computed radiography digital imaging scanner

FUJIFILM - 04547410334616

These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DP2618DT -50-
In Commercial Distribution

  • 04547410334616 ()
  • 14547410334613 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334609

These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract.
FUJIFILM CORPORATION
DP2618DT -35-
In Commercial Distribution

  • 04547410334609 ()
  • 14547410334606 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334593

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 -B20-
In Commercial Distribution

  • 04547410334593 ()
  • 14547410334590 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334586

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 -B15-
In Commercial Distribution

  • 04547410334586 ()
  • 14547410334583 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334579

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 -N30-
In Commercial Distribution

  • 04547410334579 ()
  • 14547410334576 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334562

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 -N25-
In Commercial Distribution

  • 04547410334562 ()
  • 14547410334569 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334555

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 -N20-
In Commercial Distribution

  • 04547410334555 ()
  • 14547410334552 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use

FUJIFILM - 04547410334500

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

FUJIFILM - 04547410334494

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

FUJIFILM - 04547410333435

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

FDR D-EVO II Battery Charger - 04547410333374

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

  • 04547410333374 ()


  • Diagnostic x-ray digital imaging conversion system

FUJIFILM - 04547410333312

The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-530S
In Commercial Distribution

  • 04547410333312 ()
  • 14547410333319 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410333305

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-530DL
In Commercial Distribution

  • 04547410333305 ()
  • 14547410333302 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410333299

This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
FUJIFILM CORPORATION
ES-530WE
In Commercial Distribution

  • 04547410333299 ()
  • 14547410333296 ()


  • Flexible video sigmoidoscope, reusable

FUJIFILM - 04547410333268

This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes.
FUJIFILM CORPORATION
MPC-ST
In Commercial Distribution

  • 84547410333264 ()
  • 04547410333268 ()


  • Endoscopic bite block, basic, reusable

FUJIFILM - 04547410333251

This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes.
FUJIFILM CORPORATION
MPC-P
In Commercial Distribution

  • 84547410333257 ()
  • 04547410333251 ()


  • Endoscopic bite block, basic, reusable

FUJIFILM - 04547410332377

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 FV667A
In Commercial Distribution

  • 04547410332377 ()


  • General-purpose ultrasound imaging system

FUJIFILM - 04547410332360

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 FV666A
In Commercial Distribution

  • 04547410332360 ()


  • General-purpose ultrasound imaging system

FUJIFILM - 04547410332353

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

FUJIFILM - 04547410332346

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

FUJIFILM - 04547410331493

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-12140
In Commercial Distribution

  • 04547410331493 ()
  • 24547410331497 ()


  • Endoscopic overtube, single-use

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 - 04547410331363

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

FUJIFILM - 04547410331172

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

FUJIFILM - 04547410331134

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

FUJIFILM - 04547410331127

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

FUJIFILM - 04547410331103

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

FUJIFILM - 04547410331073

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

FUJIFILM - 04547410331066

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

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 - 04547410331004

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-450D5
In Commercial Distribution

  • 04547410331004 ()
  • 14547410331001 ()


  • 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
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