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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 - 04547410432589

This product is intended to attach a balloon to a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
BA-03
In Commercial Distribution

  • 24547410432583 ()
  • 04547410432589 ()


  • Endoscope balloon positioner, reusable

DRYPIX Smart - 04547410431957

The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or DR, CT, MRI and other imaging modalities, onto a film.
FUJIFILM CORPORATION
DRYPIX SMART II : E
In Commercial Distribution

  • 04547410431957 ()


  • Diagnostic-imaging multiformat camera

FDR D-EVOII Battery Charger - 04547410431599

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

  • 04547410431599 ()


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410429046

This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes.
FUJIFILM CORPORATION
DC-08D
In Commercial Distribution

  • 14547410429043 ()
  • 04547410429046 ()


  • Flexible video duodenoscope, reusable

FUJIFILM - 04547410427059

This interface cable is intended to be used for connecting the BL-7000 to the VP-7000 and Camera Control Unit FV series via Communication Adapter.
FUJIFILM CORPORATION
CC7-301
In Commercial Distribution

  • 04547410427059 ()


  • Electrical-only medical device connection cable, reusable

FDR D-EVOIII Battery Pack - 04547410426922

A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY E
In Commercial Distribution

  • 04547410426922 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G43 - 04547410426915

The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1802 SE E
In Commercial Distribution

  • 04547410426915 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital

D-EVOIII G35 - 04547410426908

The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1801 SE E
In Commercial Distribution

  • 04547410426908 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital

FUJIFILM - 04547410426380

This product is attached to the instrument channel inlet of a FUJIFILM endoscope at medical facilities under the management of physicians. It is intended to insert an endotherapy device, to prevent leak or backflow of air and/or fluids and to enable the suction function of an endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-002
In Commercial Distribution

  • 24547410426384 ()
  • 04547410426380 ()
  • 84547410426386 ()


  • Endoscope working-channel valve, single-use

FDR AQRO - 04547410425505

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

  • 04547410425505 ()


  • Mobile basic diagnostic x-ray system, digital

FUJIFILM - 04547410425178

This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
FUJIFILM CORPORATION
EC-760S-A/L
In Commercial Distribution

  • 14547410425175 ()
  • 04547410425178 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410420685

This device is intended to be used with a video processor, light sourse, monitor, hand instruments, electorosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740S
In Commercial Distribution

  • 14547410420682 ()
  • 04547410420685 ()


  • Rigid video laparoscope

FUJIFILM - 04547410416176

FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-740UT
In Commercial Distribution

  • 14547410416173 ()
  • 04547410416176 ()


  • Flexible ultrasound gastroduodenoscope

FUJIFILM - 04547410400397

The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-580T
In Commercial Distribution

  • 14547410400394 ()
  • 04547410400397 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410400380

The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-580S
In Commercial Distribution

  • 14547410400387 ()
  • 04547410400380 ()


  • Flexible video bronchoscope, reusable

FUJIFILM - 04547410397642

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-760S-V/L
In Commercial Distribution

  • 14547410397649 ()
  • 04547410397642 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410397628

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-760Z-V/L
In Commercial Distribution

  • 04547410397628 ()
  • 14547410397625 ()


  • Flexible video colonoscope, reusable

FUJIFILM - 04547410395174

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-39CZ
In Commercial Distribution

  • 04547410395174 ()
  • 14547410395171 ()


  • Endoscope tissue removal cap, single-use

Smartooth - 08809941490084

The Disposable Probe is the tip of the Smartooth (STL-02-BK) main body. This component is composed of a sensor tip, the part in direct contact with the tooth for diagnosing tooth decay and where the laser is output, and the connecting part that connects to the main body.
Smartooth Co., Ltd.
SDP-01-BK
In Commercial Distribution

  • 08809941490084 ()
  • 08809941490091 ()
  • 08809941490022 ()
  • 08809941490114 ()

  • Length: 53.5 Millimeter
  • Outer Diameter: 13.0 Millimeter


  • Dental caries detector, optical induced fluorescence

MTS - 04260484573001

The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS
MTS Medical AG
LG380
In Commercial Distribution

  • 4260484573018 ()
  • 04260484573001 ()

  • Weight: 234 Kilogram
  • Length: 1580 Millimeter
  • Width: 1130 Millimeter
  • Height: 1500 Millimeter
3800000

  • Spark-gap lithotripsy system

Dermagold100 - 04260484571823

The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571830 ()
  • 04260484571823 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000022

  • Dermatological extracorporeal shock wave therapy system

VIASURE - 04260484571687

Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571694 ()
  • 04260484571687 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000015

  • Freestanding electric massager

DermaGold100® - 04260484571649

The DermaGold100® is intended for treatment of - diabetic footulcers - superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571649 ()
  • 04260484571656 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000014

  • Dermatological extracorporeal shock wave therapy system

OrthoGold100® - 04260484571601

Indications for Use The OrthoGold100® is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571618 ()
  • 04260484571601 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000013

  • Freestanding electric massager

Softwave Gold Li - 04260484571267

The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571274 ()
  • 04260484571267 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000024

  • Dermatological extracorporeal shock wave therapy system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380546

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver
REMED Co.,Ltd.
C-01
In Commercial Distribution

  • 08809308380546 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380539

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver
REMED Co.,Ltd.
B-01
In Commercial Distribution

  • 08809308380539 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System - 08809308380522

ALTMS Magnetic Stimulation Therapy System_Traditional ver
REMED Co.,Ltd.
A-01
In Commercial Distribution

  • 08809308380522 ()


  • Magnetic neural stimulation system

Spectra - 08809108017710

The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017714 ()
  • 08809108017710 ()
MM011500

  • Breast pump, electric

Spectra - 08809108017697

The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017691 ()
  • 08809108017697 ()


  • Breast pump, electric
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