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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A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601638
Not in Commercial Distribution

  • 10690286000213 ()
  • 00690286000216 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601594
Not in Commercial Distribution

  • 10690286000152 ()
  • 00690286000155 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00858945006836 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731958 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731941 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731934 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The G5 Single Light with Single Flat Panel Monitor, High Density Camera Ready, Single Cardanic and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192303 ()
LGH38T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, 43-inch Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168391 ()
LEH24

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173272 ()
LES24IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175801 ()
LES13INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175795 ()
LES13IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175788 ()
LES13IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175566 ()
LES11INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175559 ()
LES11IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175542 ()
LES11IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172800 ()
LES02INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172794 ()
LES02IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172787 ()
LES02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAir E-Series High Definition Dual Light, Single Flat Panel Monitor, Auxiliary is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172145 ()
LEH03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series Spindle Hybrid Single Light Dual Flat Panel Monitor High Definition is a ceiling supported lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995170981 ()
LEH000018

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series Hybrid High Definition Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168667 ()
LEH56

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168414 ()
LEH04

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The A-Series Single High Definition 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

  • 00724995200213 ()
LAH04NCNDTA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The A-Series Single High Definition 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

  • 00724995200206 ()
LAH04NC02TA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The A-Series Single High Definition 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

  • 00724995200190 ()
LAH04NC01TA

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The A-Series High Definition 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

  • 00724995199975 ()
LAH24NCNDTA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The A-Series High Definition 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

  • 00724995199968 ()
LAH24NC02TA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The A-Series High Definition 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

  • 00724995199951 ()
LAH24NC01TA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP with Adulteration strip (OX/S.G./CRE/PH)
UCP BIOSCIENCES, INC.
U-DUD-10124-RCN
In Commercial Distribution

  • 20817038020634 ()
  • 10817038020637 ()
  • 00817038020630 ()
U-DUD-10124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Drug Test Panel (8.25) AMP1000 BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50. For the detection of drugs in human urine. 25 tests/kit.
BTNX Inc
D8.25-1P29-25
In Commercial Distribution

  • 00722066005651 ()
  • 10722066005658 ()


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