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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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
VITA LE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner
Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR
LED Dental Inc
Size 2 Replacement (A-Series)
In Commercial Distribution

  • 07540201000247 ()
6101AR

  • Dental digital imaging sensor, intraoral
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
Elite CR System W/WP
CARESTREAM HEALTH, INC.
Elite CR System
Not in Commercial Distribution

  • 60889978981311 ()
8981318

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

  • 60889976579367 ()
6579361

  • Computed radiography digital imaging scanner
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, TESTED, 43 X 43
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974000375 ()
AB8135

  • Stationary basic diagnostic x-ray system, digital
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
43X43 GOS DETECTOR
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007473 ()
9G9998

  • Stationary basic diagnostic x-ray system, digital
DRX-DETECTOR 43X43 CSI FIXED
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007466 ()
9G5716

  • Stationary basic diagnostic x-ray system, digital
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
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
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
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
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