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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 - 00724995175450

The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175450 ()
LEH11NC01

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

HarmonyAIR - 00724995173494

The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173494 ()
LEH04NCNDT

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

HarmonyAIR - 00724995173470

The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173470 ()
LEH04NC01T

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

HarmonyAIR - 00724995173432

The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173432 ()
LEH04NCND

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

HarmonyAIR - 00724995176051

The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176051 ()
LEH56NC01

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

HarmonyAIR - 00724995175719

The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175719 ()
LEH13NCND

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

HarmonyAIR - 00724995175702

The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175702 ()
LEH13NC02

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

HarmonyAIR - 00724995175696

The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175696 ()
LEH13NC01

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

HarmonyAIR - 00724995175474

The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175474 ()
LEH11NCND

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

HarmonyAIR - 00724995176075

The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176075 ()
LEH56NCND

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

HarmonyAIR - 00724995176068

The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176068 ()
LEH56NC02

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

EZ-SCREEN® CUP - 00690286000520

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605204
In Commercial Distribution

  • 00690286000520 ()
  • 10690286000527 ()


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

PROFILE®-IIA - 00690286000308

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601673
In Commercial Distribution

  • 00690286000308 ()
  • 10690286000305 ()


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

PROFILE®-V MEDTOXScan® - 00690286000056

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604028
In Commercial Distribution

  • 10690286000053 ()
  • 00690286000056 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Alpine BioMed - 05704736017794

"Keypoint Focus Workstation, DAN Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072143
Not in Commercial Distribution

  • 05704736017794 ()


  • Electromyograph

Alpine BioMed - 05704736017282

"Keypoint Focus Workstation, ITA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072106
Not in Commercial Distribution

  • 05704736017282 ()


  • Electromyograph

Alpine BioMed - 05704736017275

"Keypoint Focus Workstation, NLD Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072105
Not in Commercial Distribution

  • 05704736017275 ()


  • Electromyograph

Alpine BioMed - 05704736017268

"Keypoint Focus Workstation, SPA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072104
Not in Commercial Distribution

  • 05704736017268 ()


  • Electromyograph

Alpine BioMed - 05704736017251

"Keypoint Focus Workstation, DEU Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072103
Not in Commercial Distribution

  • 05704736017251 ()


  • Electromyograph

Alpine BioMed - 05704736017206

"Keypoint Focus Workstation, ENG Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A0721BV
Not in Commercial Distribution

  • 05704736017206 ()


  • Electromyograph
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