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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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CS 7400 - 60889978470419

CS 7400 SUB-SYSTEM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978470419 ()
8470411

  • Dental computed radiography digital imaging scanner

CS 7400 - 60889978333882

PANORAMIC CASSETTE 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978333882 ()
8333882

  • Dental computed radiography digital imaging scanner

Classic CR System - 60889978113613

Classic CR System
CARESTREAM HEALTH, INC.
Classic CR System
In Commercial Distribution

  • 60889978113613 ()
8113615

  • Computed radiography digital imaging scanner

VITA CR LONG LENGTH IMAGING SYSTEM - 60889978002740

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 System - 60889978002535

VITA CR FOR IDEXX
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889978002535 ()
8002537

  • Computed radiography digital imaging scanner

Vita CR System - 60889978002528

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

  • 60889978002528 ()
8002529

  • Computed radiography digital imaging scanner

Vita Flex CR System - 60889976579367

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 - 60889976579343

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 - 60889976579336

VITA FLEX CR SYSTEM 60PPH
CARESTREAM HEALTH, INC.
Vita Flex CR System
In Commercial Distribution

  • 60889976579336 ()
6579338

  • Computed radiography digital imaging scanner

Vita CR System - 60889971919878

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 - 60889971794550

Elite CR System
CARESTREAM HEALTH, INC.
Elite CR System
In Commercial Distribution

  • 60889971794550 ()
1794551

  • Computed radiography digital imaging scanner

Vita Flex CR System - 60889971746344

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 Long Length Imaging System - 60889971746337

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

Vita Flex CR System - 60889971746320

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 - 60889971742575

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 - 60889971742568

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

  • 60889971742568 ()
1742568

  • Computed radiography digital imaging scanner

CARESTREAM DRX-Mobile Retrofit Kit - 60889971740366

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

CS 7400 - 60889971591111

CR IMAGING PLATES PAN V2 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889971591111 ()
1591114

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Long-Length Imaging System - 60889971307125

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

Vita Flex CR System - 60889971069443

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 System - 60889971069412

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

Vita Flex CR System - 60889971069405

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 System - 60889971069382

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 - 60889971069375

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 - 60889971069306

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

  • 60889971069306 ()
1069301

  • Computed radiography digital imaging scanner

CS 7600 - 60889971068408

CS7600 Imaging System for US, CA, Brazil
CARESTREAM HEALTH, INC.
CS 7600
In Commercial Distribution

  • 60889971068408 ()
1068402

  • Dental computed radiography digital imaging scanner

Vita LE CR System - 60889971067708

NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner

Vita CR System - 60889971067692

NB VITA CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971067692 ()
1067693

  • Computed radiography digital imaging scanner

Vita XE CR System - 60889971067685

NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner

CS 7200 - 60889971067470

CS 7200 Imaging Plate System
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067470 ()
1067479

  • Dental computed radiography digital imaging scanner

Vita Flex CR System - 60889971067241

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 - 60889971056504

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

  • 60889971056504 ()
1056506

  • Computed radiography digital imaging scanner

CARESTREAM DRX-1 System Detector - 60889971054968

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 System - 60889971054814

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

CS 7600 SLOT PANEL - 60889971044440

CS 7600 SLOT PANEL SIZE 0 ONLY
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971044440 ()
1044445

  • Dental computed radiography digital imaging scanner

Vita XE CR System - 60889971036940

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 - 60889971036933

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

  • 60889971036933 ()
1036938

  • Computed radiography digital imaging scanner

CS 7400 - 40889978214231

CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067513

Hygienic Sheaths #2 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067517 ()
  • 40889971067513 ()
  • 00889971067515 ()
1067511

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067506

Hygienic Sheaths #1 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067500 ()
  • 40889971067506 ()
  • 00889971067508 ()
1067503

  • Dental computed radiography digital imaging scanner
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