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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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EzSensor P - 08800018600085

EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600085 ()
1.5

  • Dental digital imaging sensor, intraoral

EzSensor P - 08800018600078

EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600078 ()
2.0

  • Dental digital imaging sensor, intraoral

EzSensor P - 08800018600061

EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600061 ()
1.5

  • Dental digital imaging sensor, intraoral

HDI2000 - 08800018600139

The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600139 ()
2.0

  • Dental digital imaging sensor, intraoral

HDI2000 - 08800018600122

The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600122 ()
1.5

  • Dental digital imaging sensor, intraoral

HDI1000 - 08800018600115

HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600115 ()
2.0

  • Dental digital imaging sensor, intraoral

HDI1000 - 08800018600108

HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600108 ()
1.5

  • Dental digital imaging sensor, intraoral

EzSensor P - 08800018600092

EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600092 ()
2.0

  • Dental digital imaging sensor, intraoral

Flashpad HD - 00840682121071

iFlashPad 17x17 inch 100um detector
GE Hualun Medical Systems Co., Ltd
4343
In Commercial Distribution

  • 00840682121071 ()


  • Stationary basic diagnostic x-ray system, digital

FlashPad - 00840682116732

No Description
GE MEDICAL SYSTEMS, INC.
5340000-7
In Commercial Distribution

  • 00840682116732 ()


  • Vascular dilator, single-use

FlashPad - 00840682116701

No Description
GE MEDICAL SYSTEMS, INC.
5340000-8
In Commercial Distribution

  • 00840682116701 ()


  • Vascular dilator, single-use

Elite CR System - 60889978981311

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 - 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

4343R Digital Image Receptor - 60889974007473

43X43 GOS DETECTOR
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007473 ()
9G9998

  • Stationary basic diagnostic x-ray system, digital

4343R Digital Image Receptor - 60889974007466

DRX-DETECTOR 43X43 CSI FIXED
CARESTREAM HEALTH, INC.
4343R Digital Image Receptor
In Commercial Distribution

  • 60889974007466 ()
9G5716

  • Stationary basic diagnostic x-ray system, digital

4343R Digital Image Receptor - 60889974000375

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

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

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

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

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

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

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

DRX - Ascend System - 60889971029881

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 CR System - 60889971024084

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 - 60889971006240

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

  • 60889971006240 ()
1006246

  • Computed radiography digital imaging scanner

Tuxedo - 07540201000247

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 - 07540201000230

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 - 07540201000223

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
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