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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Max CR system
CARESTREAM HEALTH, INC.
Max CR System
In Commercial Distribution

  • 60889971056504 ()
1056506

  • Computed radiography digital imaging scanner
FLAT TAPE ON GRID FOR 25X30 DETECTOR
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System Detector
In Commercial Distribution

  • 60889971054968 ()
1054964

  • Diagnostic x-ray digital imaging conversion system
VITA LE CR SOLUTION W / PC AND MONITOR
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971054814 ()
1054816

  • Computed radiography digital imaging scanner
QRAD DRX REFRESHED CONSOLE W/WP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971039187 ()
1039189

  • Indirect flat panel x-ray detector
NON BRANDED VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036940 ()
1036946

  • Computed radiography digital imaging scanner
VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036933 ()
1036938

  • Computed radiography digital imaging scanner
DRX-1 SYS CONSOLE ONLY W/DRX-1 SYS SW
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971035158 ()
1035153

  • Indirect flat panel x-ray detector
LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software
DRX-TRANS/FIELDPORT-DRX-1&-1CW/30DAYWAR
CARESTREAM HEALTH, INC.
DRX-Transportable System
In Commercial Distribution

  • 60889971021281 ()
1021286

  • Indirect flat panel x-ray detector
DRX-TRANSPORTSYS/UNIVMOBILEDRX-1&1C
CARESTREAM HEALTH, INC.
DRX-Transportable System
In Commercial Distribution

  • 60889971021250 ()
1021252

  • Indirect flat panel x-ray detector
CARESTREAM DRX-1 SYSTEM
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971021229 ()
1021229

  • Indirect flat panel x-ray detector
DRX-1C MOBILE CONSOLE
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
Not in Commercial Distribution

  • 60889971003812 ()
1003813

  • Indirect flat panel x-ray detector
DRX-1C MOBILE CONSOLE
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
Not in Commercial Distribution

  • 60889971003690 ()
1003698

  • Indirect flat panel x-ray detector
Classic CR System
CARESTREAM HEALTH, INC.
Classic CR System
In Commercial Distribution

  • 60889978113613 ()
8113615

  • Computed radiography digital imaging scanner
VITA CR LLI SYS FIELD INSTALLED
CARESTREAM HEALTH, INC.
VITA CR LONG LENGTH IMAGING SYSTEM
In Commercial Distribution

  • 60889978002740 ()
8002743

  • Computed radiography digital imaging scanner
VITA CR FOR IDEXX
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889978002535 ()
8002537

  • Computed radiography digital imaging scanner
VITA CR SYSTEM
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889978002528 ()
8002529

  • Computed radiography digital imaging scanner
TRIMAX 43C DETECTOR
CARESTREAM HEALTH, INC.
TRIMAX 43C
In Commercial Distribution

  • 60889976702345 ()
6702344

  • Indirect flat panel x-ray detector
VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889976579343 ()
6579346

  • Computed radiography digital imaging scanner
VITA FLEX CR SYSTEM 60PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889976579336 ()
6579338

  • Computed radiography digital imaging scanner
AY-DETECTOR, PACKED, 4343FC, TRIMAX
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343FC
In Commercial Distribution

  • 60889974160239 ()
AE4207

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,4343F
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343F
In Commercial Distribution

  • 60889974160222 ()
AE4206

  • Indirect flat panel x-ray detector
AY-DETECTOR, PACKED, 4343C, TRIMAX
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343C
In Commercial Distribution

  • 60889974160215 ()
AE4205

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,4343
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343
In Commercial Distribution

  • 60889974160208 ()
AE4204

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,3543C
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,3543C
In Commercial Distribution

  • 60889974160192 ()
AE4201

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,3543
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,3543
In Commercial Distribution

  • 60889974160185 ()
AE4200

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343FC
CARESTREAM HEALTH, INC.
DRX Core 4343FC Detector
In Commercial Distribution

  • 60889974008517 ()
AD8205

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343F
CARESTREAM HEALTH, INC.
DRX Core 4343F Detector
In Commercial Distribution

  • 60889974008500 ()
AD8204

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343C
CARESTREAM HEALTH, INC.
DRX Core 4343C Detector
In Commercial Distribution

  • 60889974008494 ()
AD8203

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343
CARESTREAM HEALTH, INC.
DRX Core 4343 Detector
In Commercial Distribution

  • 60889974008487 ()
AD8202

  • Indirect flat panel x-ray detector
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