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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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Tuxedo Intraoral Sensor Size 1 (6100A Replacement) PN 6100AR
LED Dental Inc
Size 1 Replacement (A-Series)
In Commercial Distribution

  • 07540201000230 ()
6100AR

  • Dental digital imaging sensor, intraoral
Tuxedo Intraoral Sensor Size 2 (6101 Replacement) PN 6101R
LED Dental Inc
Size 2 Replacement
In Commercial Distribution

  • 07540201000223 ()
6101R

  • Dental digital imaging sensor, intraoral
Tuxedo Intraoral Sensor Size 1 (6100 Replacement)
LED Dental Inc
Size 1 Replacement
In Commercial Distribution

  • 07540201000216 ()
6100R

  • Dental digital imaging sensor, intraoral
No Description
LED Dental Inc
Size 2
In Commercial Distribution

  • 07540201000070 ()
6101, 6101A

  • Dental digital imaging sensor, intraoral
No Description
LED Dental Inc
Size 1
In Commercial Distribution

  • 07540201000063 ()
6100, 6100A

  • Dental digital imaging sensor, intraoral
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220485 ()


  • Indirect flat panel x-ray detector
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220478 ()


  • Indirect flat panel x-ray detector
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220447 ()


  • Indirect flat panel x-ray detector
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
Elite CR System W/WP
CARESTREAM HEALTH, INC.
Elite CR System
Not in Commercial Distribution

  • 60889978981311 ()
8981318

  • Computed radiography digital imaging scanner
DRX-1 SYSTEM CONSOLE UPGRADE
CARESTREAM HEALTH, INC.
Carestream DRX-1 System
In Commercial Distribution

  • 60889978625925 ()
8625923

  • Indirect flat panel x-ray detector
LUX 35 DETECTOR /RETROFIT
CARESTREAM HEALTH, INC.
Lux Detector
In Commercial Distribution

  • 60889978623280 ()
8623282

  • Indirect flat panel x-ray detector
FOCUS HD 43 DETECTOR PACK ROK
CARESTREAM HEALTH, INC.
Focus HD 43 Detector
In Commercial Distribution

  • 60889975950617 ()
AL4713

  • Indirect flat panel x-ray detector
FOCUS HD 35 DETECTOR PACK ROK
CARESTREAM HEALTH, INC.
Focus HD 35 Detector
In Commercial Distribution

  • 60889975950600 ()
AL4712

  • Indirect flat panel x-ray detector
PACKED, LUX 35 DETECTOR, 3543
CARESTREAM HEALTH, INC.
Lux 35 Detector
In Commercial Distribution

  • 60889975950570 ()
AK7294

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

  • 60889975950563 ()
AL6764

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

  • 60889975950556 ()
AL6759

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

  • 60889975950549 ()
AL6755

  • Indirect flat panel x-ray detector
PACKED, 3543 DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 3543 Detector
In Commercial Distribution

  • 60889975950532 ()
AL6750

  • Indirect flat panel x-ray detector
PACKED, 2530C DETECTOR, DRX CORE 2
CARESTREAM HEALTH, INC.
DRX 2530C Detector
Not in Commercial Distribution

  • 60889975950525 ()
AG4322

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

  • 60889975950419 ()
AH9482

  • 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
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
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 System 45PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889971069306 ()
1069301

  • 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
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
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
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