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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/P-PCSH-P-X W/INWP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889978001194 ()
8001190

  • Stationary basic diagnostic x-ray system, digital
DRX-EVOLUTION/P-PCSH-P-X
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
Not in Commercial Distribution

  • 60889978001170 ()
8001174

  • Stationary basic diagnostic x-ray system, digital
X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704899 ()
6704894

  • Stationary basic diagnostic x-ray system, digital
X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704875 ()
6704878

  • Stationary basic diagnostic x-ray system, digital
GENERATOR GRP C 65KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701539 ()
6701536

  • Stationary basic diagnostic x-ray system, digital
GENERATOR GRP C 80KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701522 ()
6701528

  • Stationary basic diagnostic x-ray system, digital
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
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
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
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
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