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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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X3C 1600 Plus Digital Radiographic System - 00823073041028

Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X3C
In Commercial Distribution

  • 00823073041028 ()

  • Width of the Column
  • Height of the Column
  • Weight of the Column
  • Height: 2645 Millimeter
  • Length: 2450 Millimeter
  • Weight: 324 Kilogram
  • Length of the Column
  • Width: 1550 Millimeter


  • Stationary basic diagnostic x-ray system, digital

Xplorer 1600 Digital Radiographic System - 00823073041011

Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X4C
In Commercial Distribution

  • 00823073041011 ()

  • Height: 2645 Millimeter
  • Length: 2450 Millimeter
  • Weight: 324 Kilogram
  • Weight of the Column
  • Length of the Column
  • Width: 1550 Millimeter
  • Height of the Column
  • Width of the Column


  • Stationary basic diagnostic x-ray system, digital

X3C 1600 Digital Radiographic System - 00823073031029

Digital Radiographic System
Imaging Dynamics Company Ltd
1600 X3C
In Commercial Distribution

  • 00823073031029 ()

  • Width of the Column
  • Height: 2645 Millimeter
  • Length of the Column
  • Width: 1550 Millimeter
  • Height of the Column
  • Length: 2450 Millimeter
  • Weight of the Column
  • Weight: 324 Kilogram


  • Stationary basic diagnostic x-ray system, digital

Xplorer 1590 Digital Radiographic System - 00823073031012

Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X4C
In Commercial Distribution

  • 00823073031012 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital

X3C 1590 Digital Radiographic System - 00823073021020

Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X3C
In Commercial Distribution

  • 00823073021020 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital

Xplorer 1500 Digital Radiographic System - 00823073021013

Digital Radiographic System
Imaging Dynamics Company Ltd
1500 X4C
In Commercial Distribution

  • 00823073021013 ()

  • Stand and Detector Head
  • Weight: 260 Kilogram
  • Height: 212 Centimeter


  • Stationary basic diagnostic x-ray system, digital

X3C 1100 Digital Radiographic System - 00823073011021

Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X3C
In Commercial Distribution

  • 00823073011021 ()

  • Weight of Table and Detector Head
  • Table Dimensions
  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital

Xplorer 1100 Digital Radiographic System - 00823073011014

Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X4C
In Commercial Distribution

  • 00823073011014 ()

  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Weight of Table and Detector Head
  • Table Dimensions
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital

X3G Detector Head - 00823073001046

CCD Detector
Imaging Dynamics Company Ltd
X3G
In Commercial Distribution

  • 00823073001046 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital

Xaminer Detector Head - 00823073001039

CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001039 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital

X3C Detector Head - 00823073001022

CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001022 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital

Xplorer 1000 Detector Head (X4C) - 00823073001015

CCD Detector
Imaging Dynamics Company Ltd
X4C
In Commercial Distribution

  • 00823073001015 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital

ViMove+ - B758000VMPLU0

ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
DORSAVI LTD
000VMPLU0
In Commercial Distribution

  • B758000VMPLU0 ()
VMPLU

  • Psychophysiological biofeedback system

dorsaVi - V6 Low Back AMI DAP - B758000RDA891

Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Low Back AMI DAP
In Commercial Distribution

  • B75800RDA866 ()
  • B758000RDA891 ()
RS-A866

  • Psychophysiological biofeedback system

dorsaVi - V6 EMG DAP - B758000RDA890

Single use disposable application pad adhesive for use with dorsaVi Version 6 EMG Sensors.
DORSAVI LTD
V6 EMG DAP
In Commercial Distribution

  • B75800RDA865 ()
  • B758000RDA890 ()
RS-A865

  • Psychophysiological biofeedback system

dorsaVi - V6 Overwrap Adhesives - B758000RDA483

Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Overwrap Adhesives
In Commercial Distribution

  • B75800RDA445 ()
  • B758000RDA483 ()
RS-A483

  • Psychophysiological biofeedback system

dorsaVi - B758000RDA482

Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Sensor Adhesive
In Commercial Distribution

  • B758000RDA482 ()
  • B758000RDA441 ()
RS-A482

  • Psychophysiological biofeedback system

Movement Suite / V5 Sensor Kit - B7580000VMV50

Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
DORSAVI LTD
0000VMV50
In Commercial Distribution

  • B7580000VMV50 ()
VMV50

  • Psychophysiological biofeedback system

Professional Suite - B7580000PS100

Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
DORSAVI LTD
0000PS100
In Commercial Distribution

  • B7580000PS100 ()
PS100

  • Psychophysiological biofeedback system

30 Minute Disposable Application Pad - B758000035630

Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
DORSAVI LTD
30Min-DAP
In Commercial Distribution

  • B758000035630 ()
  • B758000RDA326 ()
0356-30

  • Psychophysiological biofeedback system

2020i Straight Arm - 00817100020162

2020i Radiographic Straight Arm system variable focal distance left loading only
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000i
In Commercial Distribution

  • 00817100020162 ()
2020SA

  • Stationary basic diagnostic x-ray system, digital

2020i Imaging Hand System - 00817100020155

Dedicated Hand X-Ray system
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR420i
In Commercial Distribution

  • 00817100020155 ()
HDR

  • Stationary basic diagnostic x-ray system, digital

2020 Imaging Podiatry System HF - 00817100020148

X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital

2020 Imaging Podiatry System - 00817100020131

20/20 BiDirectional PDR X-ray Machine.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR400i
In Commercial Distribution

  • 00817100020131 ()
BD715

  • Stationary basic diagnostic x-ray system, digital

Dynamic DR Room - 00817100020100

Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
RF6000
In Commercial Distribution

  • 00817100020100 ()


  • Stationary basic diagnostic x-ray system, digital

Overhead Tube Crane - 00817100020094

NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5200
In Commercial Distribution

  • 00817100020094 ()


  • Stationary basic diagnostic x-ray system, digital

Overhead Tube Crane Ceiling Suspension - 00817100020070

Manual ceiling suspension tube stand ONLY
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5100
In Commercial Distribution

  • 00817100020070 ()


  • Stationary basic diagnostic x-ray system, digital

Millenium Floor Mounted Tube Stand - 00817100020063

Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR100
In Commercial Distribution

  • 00817100020063 ()


  • Stationary basic diagnostic x-ray system, digital

Advanced Universal U-Arm Stand 4000 - 00817100020056

Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3500B
In Commercial Distribution

  • 00817100020056 ()


  • Stationary basic diagnostic x-ray system, digital

Advanced Universal U-Arm Stand 3000 - 00817100020049

Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3002
In Commercial Distribution

  • 00817100020049 ()


  • Stationary basic diagnostic x-ray system, digital

U-Arm System - 00817100020032

Universal U-arm system - With Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3000
In Commercial Distribution

  • 00817100020032 ()


  • Stationary basic diagnostic x-ray system, digital

U-Arm System Basic - 00817100020025

Universal U-arm system - Motorized.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3001
In Commercial Distribution

  • 00817100020025 ()


  • Stationary basic diagnostic x-ray system, digital

Straight Arm System - 00817100020018

Universal Radiographic Straight Arm system variable focal distance left loading Only.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000
In Commercial Distribution

  • 00817100020018 ()


  • Stationary basic diagnostic x-ray system, digital

CuattroDR - B269SWR00069MD0

CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

Freespira - B185SM40500

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system

FST5 - B185FS059370

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system

DRX-Evolution Plus System - 60889971026170

DRX-EVOLUTN PREMIUM CSH WS W/ SLIM E-BOX
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
Not in Commercial Distribution

  • 60889971026170 ()
1026178

  • Stationary basic diagnostic x-ray system, digital

DRX-Evolution Plus System - 60889971016140

DRX EVO FIXD ELE TBL MDL VX3733-TAB
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
Not in Commercial Distribution

  • 60889971016140 ()
1016146

  • Stationary basic diagnostic x-ray system, digital

Kangaroo - 50885380198791

Kangaroo NTrainer Handpiece Tubing
Cardinal Health 200, LLC
1000NT-T
In Commercial Distribution

  • 10885380198793 ()
  • 50885380198791 ()
1000NT-T

  • Psychophysiological biofeedback system

NTRAINER - 50885380195561

NTrainer System 2.0 Patient Receiver Tubes (10-pack)
Cardinal Health 200, LLC
510NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195561 ()
510NT

  • Psychophysiological biofeedback system
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