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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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HarmonyAIR - 00724995167219

The G5 Single Light, Camera Hybrid, Single Flat Panel Monitor, Single Cardanic and Spring Arm is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167219 ()
LGH25N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995167172

The G5 Single Light, with Camera with ConnectPoint Express, Single Flat Panel Monitor and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167172 ()
LGH14NCT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995166595

The Single High Density M5, No Control with Single Flat Panel Monitor Spring Arm, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166595 ()
LMH24NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995214203

The E-Series High Density Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214203 ()
LEH14NCND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995214197

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214197 ()
LEH14NC02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995214180

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214180 ()
LEH14NC01

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995214142

The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214142 ()
LES31NCNDT

  • Medical monitor/light mount

HarmonyAIR - 00724995214135

The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214135 ()
LES31NC02T

  • Medical monitor/light mount

HarmonyAIR - 00724995214128

The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214128 ()
LES31NC01T

  • Medical monitor/light mount

EZ-SCREEN® CUP - 00690286000698

A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605211
In Commercial Distribution

  • 10690286000695 ()
  • 00690286000698 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

MD DrugScreen - 00860003196977

CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196977 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

MD DrugScreen - 00860003196960

CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196960 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

MD DrugScreen - 00860003196946

CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDMA500/MTD300/OXY100/BUP10)+ (OXI-SG-PH)
Medical Disposables Corp
MDC-6125R-A3
In Commercial Distribution

  • 00860003196946 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Radlink GPS Bucky Cart - 00866389000136

The Radlink GPS Bucky Cart is a manually operated cart with one compartment that is meant for housing and transporting flat panel detectors.
RADLINK, INC.
Bucky
In Commercial Distribution

  • 00866389000136 ()


  • X-ray film cassette holder

U-Screen - 00858998006180

U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOBCLIA
Not in Commercial Distribution

  • 00858998006180 ()
USSCupA-7MOBCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

HarmonyAIR - 00724995199166

The G5 Dual Light with Single Flat Panel Monitor, HD Camera Ready and Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995199166 ()
LGH42CP

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995192297

The G5 Single Light with Single Flat Panel Monitor, High Density Camera Ready, Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192297 ()
LGH38

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995192150

The G5 Dual Light with Single Flat Panel Monitor, No Camera, Single Cardanic with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192150 ()
LG41T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995192143

The G5 Dual Light with Single Flat Panel Monitor Mount, No Camera, No Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192143 ()
LG11FT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995191825

The M7/M5 High Density Package, Single Flat Panel Monitor Mount, without Hub Spacer, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191825 ()
LMH08T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995191788

The M7 Single High Density Package with Hub Spacer, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191788 ()
LMH29T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191702

The M7 Single Package with Single High Density Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191702 ()
LM29T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995191689

The M7 Single Package with Single High Density Flat Panel Monitor Mount, No Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191689 ()
LM09T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191535

The M5 High Density Single Package with Hub Spacer, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191535 ()
LMH24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995192006

The G5 Single Light with Single Flat Panel Monitor Mount, Non Camera, Fixed with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192006 ()
LG07FT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995200336

The A-Series Single Light 35-inch, Single Flat Panel Monitor, NO Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200336 ()
LAS04NCNDTA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995200329

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200329 ()
LAS04NC02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995200312

The A-Series Single Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200312 ()
LAS04NC01TA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995200121

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, No Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200121 ()
LAH04INNDA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995200114

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200114 ()
LAH04IN02A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995200107

The A-Series Single High Definition Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200107 ()
LAH04IN01A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995200091

The A-Series Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200091 ()
LAS24NCNDTA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995200084

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200084 ()
LAS24NC02TA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995200077

The A-Series Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200077 ()
LAS24NC01TA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995199883

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199883 ()
LAH24INNDA

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995199876

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199876 ()
LAH24IN02A

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995199869

The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199869 ()
LAH24IN01A

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199463

The A-Series High Definition Dual Light, Single Flat Panel Monitor, No Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199463 ()
LAH02INNDTA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199456

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199456 ()
LAH02IN02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199449

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199449 ()
LAH02IN01TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199432

The A-Series High Definition Dual Light, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199432 ()
LAH02NCNDA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995199425

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199425 ()
LAH02NC02A

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199418

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199418 ()
LAH02NC01A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

Identify® Diagnostics Drug Test Cards - 10850721007690

Identify® Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ25
In Commercial Distribution

  • 20850721007697 ()
  • 10850721007690 ()
  • 00850721007693 ()
ID-CP12-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identify®Diagnostics Drug Test Cards - 10850721007652

Identify®Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP
In Commercial Distribution

  • 20850721007659 ()
  • 10850721007652 ()
  • 00850721007655 ()
ID-CP12-DIP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identify® Diagnostics Drug Test Cards - 10850721007607

Identify® Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ10
In Commercial Distribution

  • 20850721007604 ()
  • 10850721007607 ()
  • 00850721007600 ()
ID-CP12-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identify® Diagnostics Drug Test Cards - 10850721007539

Identify® Diagnostics Drug Test Cards 12 panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ5
In Commercial Distribution

  • 20850721007536 ()
  • 10850721007539 ()
  • 00850721007532 ()
ID-CP12-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

UScreen® - 10817405021366

U-Screen Squared Integrated Cup with Adulterants (CR/Ni/pH) 10 Panel Drug Screen (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
USSCupA-10NT
In Commercial Distribution

  • 10817405021366 ()
  • 00817405021369 ()
USSCupA-10NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

u-CupTM Drug Test Screen - 10817038022266

12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038022263 ()
  • 10817038022266 ()
  • 00817038022269 ()
U-DUD-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

UCP Home Drug Screening Test Cards - 10817038021474

UCP Home Drug Screening Test Cards 12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-DOA-3124
In Commercial Distribution

  • 20817038021471 ()
  • 10817038021474 ()
  • 00817038021477 ()
U-DOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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