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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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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

NTRAINER - 50885380195554

NTrainer System 2.0 Patient Receiver Tubes (5-pack)
Cardinal Health 200, LLC
505NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195554 ()
505NT

  • Psychophysiological biofeedback system

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

CuattroDR - B269SWR00069MD0

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

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

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
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