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
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