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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AY-DETECTOR, COMPLETE, DRX 1-C
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000160 ()
AB3753

  • Indirect flat panel x-ray detector
Elevating Table (320) - DRX Evo Plus
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739247 ()
1739242

  • Indirect flat panel x-ray detector
QRAD DRX REFRESHED CONSOLE W/WP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971039187 ()
1039189

  • Indirect flat panel x-ray detector
DRX-1 SYS CONSOLE ONLY W/DRX-1 SYS SW
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971035158 ()
1035153

  • 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
TDR 3543C DETECTOR / FOR DIRECTVIEW SW
CARESTREAM HEALTH, INC.
TDR 3543C Detector
In Commercial Distribution

  • 60889971067326 ()
1067321

  • Indirect flat panel x-ray detector
TRIMAX 43C DETECTOR
CARESTREAM HEALTH, INC.
TRIMAX 43C
In Commercial Distribution

  • 60889976702345 ()
6702344

  • Indirect flat panel x-ray detector
FOCUS 43C DETECTOR/RETROFIT
CARESTREAM HEALTH, INC.
Focus 43C Detector
In Commercial Distribution

  • 60889976702338 ()
6702336

  • Indirect flat panel x-ray detector
TRIMAX 35C DETECTOR
CARESTREAM HEALTH, INC.
TRIMAX 35C
In Commercial Distribution

  • 60889976701133 ()
6701130

  • Indirect flat panel x-ray detector
CARESTREAM FOCUS 35C DETECTOR/RETROFIT
CARESTREAM HEALTH, INC.
Focus 35C Detector
In Commercial Distribution

  • 60889976701126 ()
6701122

  • 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
DR-PANEL-LT1114-L / R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN292
In Commercial Distribution

  • 00817100020513 ()


  • Indirect flat panel x-ray detector
RF 11X14 Sensor Panel -R/-L
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN291
In Commercial Distribution

  • 00817100020483 ()


  • Indirect flat panel x-ray detector
RF 14X17 Sensor Panel-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN290
In Commercial Distribution

  • 00817100020315 ()


  • Indirect flat panel x-ray detector
IR 14X17 Wireless GOS Flat Panel Detector -R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN200
In Commercial Distribution

  • 00817100020254 ()


  • Indirect flat panel x-ray detector
No Description
Corindus, Inc.
101
In Commercial Distribution

  • 00816280021013 ()
101

  • Radiation shielding panel, portable/mobile
SCATPAD STSN 802 Table Skirt Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
STSN 802
In Commercial Distribution

  • 00814907020678 ()
STSN 802

  • Radiation shielding panel, portable/mobile
SCATPAD SJAA 601-XJugular Access / TIPS Custom Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Split Fenestration, Airtex Fabric, Single Level, Tape
CARDIO-MEDICAL PRODUCTS, INC.
SJAA 601-X
In Commercial Distribution

  • 10814907020668 ()
  • 00814907020661 ()
SJAA 601-X

  • Radiation shielding panel, portable/mobile
SCATPAD SEPA 463-X-AFCath/EP Multi-Purpose Extra Large Specialty Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Airtex Fabric, Scoop and Adjustable Fenestration Tri Level, Tape
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 463-X-AF
In Commercial Distribution

  • 10814907020651 ()
  • 00814907020654 ()
SEPA 463-X-AF

  • Radiation shielding panel, portable/mobile
SCATPAD SEPA 453-X EP Specialty Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration, Tri Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 453-X
In Commercial Distribution

  • 10814907020644 ()
  • 00814907020647 ()
SEPA 453-X

  • Radiation shielding panel, portable/mobile
SCATPAD SMA 123 Multipurpose Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Tri Level
CARDIO-MEDICAL PRODUCTS, INC.
SMA 123
In Commercial Distribution

  • 00814907020630 ()
SMA 123

  • Radiation shielding panel, portable/mobile
SCATPAD SEPA 402-A EP Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 402-A
In Commercial Distribution

  • 10814907020620 ()
  • 00814907020623 ()
SEPA 402-A

  • Radiation shielding panel, portable/mobile
SCATPAD SDFA 702 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Shield Size 5” x 12” Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SDFA 702
In Commercial Distribution

  • 10814907020606 ()
  • 00814907020609 ()
SDFA 702

  • Radiation shielding panel, portable/mobile
SCATPAD SDFA 701 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Shield Size 5” x 12” Single Level
CARDIO-MEDICAL PRODUCTS, INC.
SDFA 701
In Commercial Distribution

  • 10814907020590 ()
  • 00814907020593 ()
SDFA 701

  • Radiation shielding panel, portable/mobile
SCATPAD SPA 502 Peripheral Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SPA 502
In Commercial Distribution

  • 10814907020576 ()
  • 00814907020579 ()
SPA 502

  • Radiation shielding panel, portable/mobile
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