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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AY-DETECTOR, DRX-1C, OEM, PACKED
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000191 ()
AB4073

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, TDR3543C
CARESTREAM HEALTH, INC.
TDR 3543C Detector
In Commercial Distribution

  • 60889974000184 ()
AB3966

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, TDR3543
CARESTREAM HEALTH, INC.
TDR 3543 Detector
In Commercial Distribution

  • 60889974000177 ()
AB3964

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, DRX 1-C
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000160 ()
AB3753

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, DRX-1
CARESTREAM HEALTH, INC.
DRX-1 Detector
In Commercial Distribution

  • 60889974000153 ()
AB3752

  • Indirect flat panel x-ray detector
AY-DETECTOR-PACKED-25X30
CARESTREAM HEALTH, INC.
DRX 2530C DETECTOR
In Commercial Distribution

  • 60889974000078 ()
9J2791

  • Indirect flat panel x-ray detector
IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

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

  • 60889971794550 ()
1794551

  • Computed radiography digital imaging scanner
Vita Flex CR dental panoramic kit
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971746344 ()
1746346

  • Computed radiography digital imaging scanner
VITA FLEX CR LLI KIT
CARESTREAM HEALTH, INC.
Vita Flex CR Long Length Imaging System
In Commercial Distribution

  • 60889971746337 ()
1746338

  • Computed radiography digital imaging scanner
TRIMAX CR SYSTEM 40 MADE IN CH, PC/M
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971746320 ()
1746320

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

  • 60889971742575 ()
1742576

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

  • 60889971742568 ()
1742568

  • Computed radiography digital imaging scanner
Motion Mobile DR Retrofit Kit
CARESTREAM HEALTH, INC.
CARESTREAM DRX-Mobile Retrofit Kit
Not in Commercial Distribution

  • 60889971740366 ()
1740364

  • Diagnostic x-ray digital imaging conversion system
DIRECTVIEW CR LONG-LENGTH IMAGING SYSTEM
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Long-Length Imaging System
Not in Commercial Distribution

  • 60889971307125 ()
1307123

  • Computed radiography digital imaging scanner
UPGRADE Vita Flex 30 to 45 PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971069443 ()
1069442

  • Computed radiography digital imaging scanner
NB Vita Flex CR 45PPH solution PC/Monito
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069412 ()
1069418

  • Computed radiography digital imaging scanner
NB Vita Flex CR 30PPH solution PC/Monito
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069405 ()
1069400

  • Computed radiography digital imaging scanner
Vita Flex CR 45PPH solution PC/Monitor
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069382 ()
1069384

  • Computed radiography digital imaging scanner
Vita Flex CR 30PPH solution PC/Monitor
CARESTREAM HEALTH, INC.
Vita Flex CR System
Not in Commercial Distribution

  • 60889971069375 ()
1069376

  • Computed radiography digital imaging scanner
Vita Flex CR System 45PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971069306 ()
1069301

  • Computed radiography digital imaging scanner
NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner
NB VITA CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971067692 ()
1067693

  • Computed radiography digital imaging scanner
NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner
TDR 3543C DETECTOR / FOR DIRECTVIEW SW
CARESTREAM HEALTH, INC.
TDR 3543C Detector
In Commercial Distribution

  • 60889971067326 ()
1067321

  • Indirect flat panel x-ray detector
Vita Flex CR System 30PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971067241 ()
1067248

  • Computed radiography digital imaging scanner
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
VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

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

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner
DRX-1C MOBILE CONSOLE
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
Not in Commercial Distribution

  • 60889971003812 ()
1003813

  • Indirect flat panel x-ray detector
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