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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Assembly-PACKED, DRX CORE, 4343FC
CARESTREAM HEALTH, INC.
DRX Core 4343FC Detector
In Commercial Distribution

  • 60889974008517 ()
AD8205

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343F
CARESTREAM HEALTH, INC.
DRX Core 4343F Detector
In Commercial Distribution

  • 60889974008500 ()
AD8204

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343C
CARESTREAM HEALTH, INC.
DRX Core 4343C Detector
In Commercial Distribution

  • 60889974008494 ()
AD8203

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343
CARESTREAM HEALTH, INC.
DRX Core 4343 Detector
In Commercial Distribution

  • 60889974008487 ()
AD8202

  • Indirect flat panel x-ray detector
AY-PACKED, DRX CORE, 3543C
CARESTREAM HEALTH, INC.
DRX Core 3543C Detector
In Commercial Distribution

  • 60889974008470 ()
AD8201

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 3543
CARESTREAM HEALTH, INC.
DRX Core 3543 Detector
In Commercial Distribution

  • 60889974008463 ()
AD8200

  • Indirect flat panel x-ray detector
AY-PACKED, 4343FC DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343FC DETECTOR
In Commercial Distribution

  • 60889974007541 ()
AD4403

  • Indirect flat panel x-ray detector
AY-PACKED, 4343F DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343F DETECTOR
In Commercial Distribution

  • 60889974007534 ()
AD4402

  • Indirect flat panel x-ray detector
AY-PACKED, 4343C DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343C DETECTOR
In Commercial Distribution

  • 60889974007527 ()
AD4401

  • Indirect flat panel x-ray detector
AY-PACKED, 4343 DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343 DETECTOR
In Commercial Distribution

  • 60889974007510 ()
AD4400

  • Indirect flat panel x-ray detector
AY-PKD-DRX-1C DETECTOR-CHINA
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000801 ()
AB5213

  • Indirect flat panel x-ray detector
AY-DETECTOR-2530-COMPLETE-OEM
CARESTREAM HEALTH, INC.
DRX 2530C DETECTOR
In Commercial Distribution

  • 60889974000795 ()
AB0710

  • Indirect flat panel x-ray detector
AY-PACKED-3543C DETECTOR-DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 3543C Detector
In Commercial Distribution

  • 60889974000238 ()
AC2603

  • Indirect flat panel x-ray detector
AY-PACKED-3543 DETECTOR-DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 3543 Detector
In Commercial Distribution

  • 60889974000221 ()
AC2600

  • Indirect flat panel x-ray detector
AY-DETECTOR, DRX-1C, OEM, PACKED
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000191 ()
AB4073

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, TDR3543C
CARESTREAM HEALTH, INC.
TDR 3543C Detector
In Commercial Distribution

  • 60889974000184 ()
AB3966

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, TDR3543
CARESTREAM HEALTH, INC.
TDR 3543 Detector
In Commercial Distribution

  • 60889974000177 ()
AB3964

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, DRX 1-C
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000160 ()
AB3753

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, DRX-1
CARESTREAM HEALTH, INC.
DRX-1 Detector
In Commercial Distribution

  • 60889974000153 ()
AB3752

  • Indirect flat panel x-ray detector
AY-DETECTOR-PACKED-25X30
CARESTREAM HEALTH, INC.
DRX 2530C DETECTOR
In Commercial Distribution

  • 60889974000078 ()
9J2791

  • Indirect flat panel x-ray detector
DRX-TRANS/FIELDPORT-DRX-1&-1CW/30DAYWAR
CARESTREAM HEALTH, INC.
DRX-Transportable System
In Commercial Distribution

  • 60889971021281 ()
1021286

  • Indirect flat panel x-ray detector
DRX-TRANSPORTSYS/UNIVMOBILEDRX-1&1C
CARESTREAM HEALTH, INC.
DRX-Transportable System
In Commercial Distribution

  • 60889971021250 ()
1021252

  • Indirect flat panel x-ray detector
CARESTREAM DRX-1 SYSTEM
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971021229 ()
1021229

  • Indirect flat panel x-ray detector
DRX-1C MOBILE CONSOLE
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
Not in Commercial Distribution

  • 60889971003812 ()
1003813

  • Indirect flat panel x-ray detector
DRX-1C MOBILE CONSOLE
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
Not in Commercial Distribution

  • 60889971003690 ()
1003698

  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
F4343-AW
In Commercial Distribution

  • 08806095896144 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
F4335-AW
In Commercial Distribution

  • 08806094744934 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4343-AWM
In Commercial Distribution

  • 08806094458220 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4335-AWM
In Commercial Distribution

  • 08806094458213 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4343-W
In Commercial Distribution

  • 08806088512266 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S3025-W
In Commercial Distribution

  • 08806088512211 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4335-W
In Commercial Distribution

  • 08806086571210 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4343-AW
In Commercial Distribution

  • 08801643990107 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4335-AW
In Commercial Distribution

  • 08801643990091 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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.
S4335-WV
In Commercial Distribution

  • 08801643431419 ()


  • Indirect flat panel x-ray detector
Radiation Protection System Upgrade from Floor to 48" Hybrid Monorail Design; ZGH-6-5H Upgrade to ZGHH-CM48
TIDI PRODUCTS, LLC
ZGHH-CM48
In Commercial Distribution

  • 00618125190096 ()
ZGHH-CM48

  • Radiation shielding panel, portable/mobile
Radiation Protection System Upgrade from Floor to Hybrid Monorail Design; ZGM-6-5H Upgrade to ZGHH-CMHSA
TIDI PRODUCTS, LLC
ZGHH-CMHSA
In Commercial Distribution

  • 00618125185153 ()
ZGHH-CMHSA

  • Radiation shielding panel, portable/mobile
Radiation Protection System Monorail Leaded Acrylic Shield
TIDI PRODUCTS, LLC
ZGCMRS
In Commercial Distribution

  • 00618125176809 ()
ZGCMRS

  • Radiation shielding panel, portable/mobile
Radiation Protection System - Body Shield with Extension Rail
TIDI PRODUCTS, LLC
ZG48
In Commercial Distribution

  • 00618125176304 ()
ZG48

  • Radiation shielding panel, portable/mobile
Radiation Protection System Floor Unit
TIDI PRODUCTS, LLC
ZGM-6-5H
In Commercial Distribution

  • 00618125176250 ()
ZGM-6-5H

  • Radiation shielding panel, portable/mobile
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