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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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X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F
CARESTREAM HEALTH, INC.
DRX-COMPASS X-RAY SYSTEM
In Commercial Distribution

  • 60889978621613 ()
8621617

  • Stationary basic diagnostic x-ray system, digital
DRX-EVOLUTION/P-PCSH-P-X
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
Not in Commercial Distribution

  • 60889978001170 ()
8001174

  • Stationary basic diagnostic x-ray system, digital
X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704899 ()
6704894

  • Stationary basic diagnostic x-ray system, digital
X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889976704875 ()
6704878

  • Stationary basic diagnostic x-ray system, digital
GENERATOR GRP C 65KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701539 ()
6701536

  • Stationary basic diagnostic x-ray system, digital
GENERATOR GRP C 80KW 3P 380-480 VAC
CARESTREAM HEALTH, INC.
Value Systems
In Commercial Distribution

  • 60889976701522 ()
6701528

  • Stationary basic diagnostic x-ray system, digital
ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889976565667 ()
6565667

  • Stationary basic diagnostic x-ray system, digital
CARESTREAM DRX BABIX HOLDER
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889976557655 ()
6557656

  • Stationary basic diagnostic x-ray system, digital
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
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
80KW GENERATOR/FOR DRX-EVOLUTION
CARESTREAM HEALTH, INC.
CARESTREAM DRX-EVOLUTION
In Commercial Distribution

  • 60889971963789 ()
1963784

  • Stationary basic diagnostic x-ray system, digital
The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF85-SP
In Commercial Distribution

  • 08806095799643 ()


  • Stationary basic diagnostic x-ray system, digital
The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF85-3P
In Commercial Distribution

  • 08806095799636 ()


  • Stationary basic diagnostic x-ray system, digital
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC70
In Commercial Distribution

  • 08806088670560 ()


  • Stationary basic diagnostic x-ray system, digital
The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A
In Commercial Distribution

  • 08806088566313 ()


  • Stationary basic diagnostic x-ray system, digital
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital
The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital
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