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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 - 04547410210422

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
WB4324FW2
In Commercial Distribution

  • 34547410210423 ()
  • 04547410210422 ()
  • 44547410210420 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

Magazine L - 04547410207767

Large magazine : 14”x17” film size
FUJIFILM CORPORATION
DPX LITE MAGAZINE L : E
In Commercial Distribution

  • 04547410207767 ()


  • Diagnostic-imaging multiformat camera

Magazine S - 04547410207743

Small magazine : 10”x12”, 26x36cm, 8”x10” film size
FUJIFILM CORPORATION
DPX LITE MAGAZINE S : E
In Commercial Distribution

  • 04547410207743 ()


  • Diagnostic-imaging multiformat camera

DRYPIX Lite - 04547410207699

The DRYPIX Lite is a printer that prints onto film images received via the DICOM network from modalities such as FCR image readers and CT or MRI scanners. The DRYPIX Lite can also be used to print onto film images from modalities or image processors that are not on the DICOM network.
FUJIFILM CORPORATION
DRYPIX 2000
In Commercial Distribution

  • 04547410207699 ()


  • Diagnostic-imaging multiformat camera

FDR D-EVO plus C35s - 04547410196870

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 611 SE WIRED E
In Commercial Distribution

  • 04547410196870 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C35i - 04547410196863

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 611 SE E
In Commercial Distribution

  • 04547410196863 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410195743

This product is intended to be used in conjunction with applicable model FUJIFILM endoscopes having a water jet (WJ) channel to deliver sterile water or fluids. Do not use this product for any other purpose.
FUJIFILM CORPORATION
JT-500
In Commercial Distribution

  • 04547410195743 ()
  • 04547410331554 ()


  • Flexible video colonoscope, reusable

SE storage case - 04547410193565

Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR602 SE CASE E
In Commercial Distribution

  • 04547410193565 ()


  • Stationary basic diagnostic x-ray system, digital

FCR PRIMA II - 04547410189988

The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 391RU
In Commercial Distribution

  • 04547410189988 ()


  • Computed radiography digital imaging scanner

Li-ion Battery - 04547410180213

A battery pack for the flat panel sensor (DR-ID 601SE, DR-ID 602SE and DR-ID 611SE) used in wireless communication mode.
FUJIFILM CORPORATION
DR601 SE BATTERY E
In Commercial Distribution

  • 04547410180213 ()


  • Stationary basic diagnostic x-ray system, digital

DRYPIX Plus - 04547410180077

The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format.
FUJIFILM CORPORATION
DRYPIX 4000
In Commercial Distribution

  • 04547410180077 ()


  • Diagnostic-imaging multiformat camera

DRYPIX Plus - 04547410180060

The Fuji Medical Dry Laser Imager DRYPIX 4000 is a device that prints digital image data, transferred via the DICOM network from the FCR Image Reader or CT, MRI and other imaging modalities, onto dedicated film in the selected format.
FUJIFILM CORPORATION
DRYPIX 4000
In Commercial Distribution

  • 04547410180060 ()


  • Diagnostic-imaging multiformat camera

DR-ID 600MP - 04547410178678

Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 600/601 MP E
In Commercial Distribution

  • 04547410178678 ()


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410138511

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-601
In Commercial Distribution

  • 24547410138515 ()
  • 04547410138511 ()


  • Luminal device flushing tubing set, reusable

SE storage case - 04547410134667

Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR600 SE CASE E
In Commercial Distribution

  • 04547410134667 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410134551

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410132786

This product is a single-use suction button with built-in suction connector for compatible model FUJIFILM endoscopes. When attached to an endoscope and connected to an aspirator (suction source), it is used to control the suctioning of fluids, patient material, etc. through the instrument channel of the endoscope by a medical professional appropriately trained in performing endoscopy. Do not use this product for any other purposes.
FUJIFILM CORPORATION
SB-602
In Commercial Distribution

  • 24547410132780 ()
  • 04547410132786 ()


  • Endoscope suction valve, single-use

FUJIFILM - 04547410111910

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-501JT/A
In Commercial Distribution

  • 24547410111914 ()
  • 04547410111910 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410111408

This product is the balloon attachment tool used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
BA-BU1
In Commercial Distribution

  • 04547410111408 ()
  • 34547410111409 ()


  • Flexible ultrasound bronchoscope

FUJIFILM - 04547410111392

This product is used for keeping the air tightness of the forceps channel valve of the endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-BU1
In Commercial Distribution

  • 04547410111392 ()
  • 84547410111398 ()
  • 24547410111396 ()


  • Flexible ultrasound bronchoscope

FUJIFILM - 04547410104349

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

FUJIFILM - 04547410097603

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

FUJIFILM - 04547410093292

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

FUJIFILM - 04547410093285

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

FUJIFILM - 04547410079371

This product is the waterproof cap used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WA-7000
In Commercial Distribution

  • 34547410079372 ()
  • 04547410079371 ()


  • Endoscope fluid protection cap

FUJIFILM - 04547410079357

This product is used in medical facilityes and attached to our endoscope to prevent air leak or backflow of body fluid from the forceps inlet. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-LL2
In Commercial Distribution

  • 34547410079358 ()
  • 04547410079357 ()
  • 84547410079353 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410079326

This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow or air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-DV7
In Commercial Distribution

  • 34547410079327 ()
  • 04547410079326 ()
  • 84547410079322 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410079302

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-503/A
In Commercial Distribution

  • 24547410079306 ()
  • 04547410079302 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410079197

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-500B
In Commercial Distribution

  • 04547410079197 ()
  • 04547410331387 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410079173

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. Do not use this product for any other purpose.
FUJIFILM CORPORATION
ST-01B
In Commercial Distribution

  • 24547410079177 ()
  • 04547410079173 ()


  • Endoscope balloon positioner, reusable

FUJIFILM - 04547410079159

This product is used for forward water conveyance to wash digestive tract in diagnosis with a water pump and our specified endoscope. This product is the tube for forward water conveyance to wash digestive tract in diagnosis, which connects between Water Jet inlet of Endoscope and a water pump.
FUJIFILM CORPORATION
JA-500
In Commercial Distribution

  • 04547410079159 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410079142

This product is the ventilation adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AD-7
In Commercial Distribution

  • 34547410079143 ()
  • 04547410079142 ()


  • Endoscope channel-opening adaptor

FUJIFILM - 04547410079128

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
WB11002FW2
In Commercial Distribution

  • 34547410079129 ()
  • 04547410079128 ()
  • 44547410079126 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

FUJIFILM - 04547410079104

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
WB4321FW2
In Commercial Distribution

  • 34547410079105 ()
  • 04547410079104 ()
  • 44547410079102 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

FUJIFILM - 04547410079050

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
WB3224FW2
In Commercial Distribution

  • 34547410079051 ()
  • 04547410079050 ()
  • 44547410079058 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

FUJIFILM - 04547410079043

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
WB3218FW2
In Commercial Distribution

  • 34547410079044 ()
  • 04547410079043 ()
  • 44547410079041 ()


  • Surgical instrument/endoscope cleaning utensil, reusable

FUJIFILM - 04547410343052

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, airways and tracheobronchial tree under the management of physicians at medical facilities.
FUJIFILM CORPORATION
PB2020-M
In Commercial Distribution

  • 04547410343052 ()


  • Surgical ultrasound imaging transducer

FUJIFILM - 04547410341294

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

FUJIFILM - 04547410339437

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

FUJIFILM - 04547410339420

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

FUJIFILM - 04547410337402

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

FUJIFILM - 04547410337396

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

FDR-2000BPY - 04547410336047

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

D-EVO II C24 - 04547410335286

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

FUJIFILM - 04547410334999

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

FUJIFILM - 04547410334982

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

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 - 04547410334531

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
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