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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 - 00724995214265

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

  • 00724995214265 ()
LEH14NCNDT

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

HarmonyAIR - 00724995214258

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

  • 00724995214258 ()
LEH14NC02T

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

HarmonyAIR - 00724995214241

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

  • 00724995214241 ()
LEH14NC01T

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

HarmonyAIR - 00724995192464

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

  • 00724995192464 ()
LGH51T

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

HarmonyAIR - 00724995192419

The G5 Dual Light with Single Flat Panel Monitor Mount, 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

  • 00724995192419 ()
LGH42

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

HarmonyAIR - 00724995192402

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

  • 00724995192402 ()
LGH12T

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

HarmonyAIR - 00724995192280

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

  • 00724995192280 ()
LGH08T

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

HarmonyAIR - 00724995191740

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

  • 00724995191740 ()
LM08T

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

HarmonyAIR - 00724995170660

The HarmonyAIR E-Series 59-inch Auxiliary Arm 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

  • 00724995170660 ()
LEH0070

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

Rapid Response - 00722066004906

One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
BTNX Inc
D12.11.1-1VA
In Commercial Distribution

  • 00722066004906 ()


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

CSI - 00850798007664

CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-8105
In Commercial Distribution

  • 00850798007688 ()
  • 00850798007671 ()
  • 00850798007664 ()


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

Alpine BioMed - 05704736017183

"Keypoint Focus Notebook System, DAN Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071143
Not in Commercial Distribution

  • 05704736017183 ()


  • Electromyograph

Alpine BioMed - 05704736017145

"Keypoint Focus Notebook System, DEU Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071103
Not in Commercial Distribution

  • 05704736017145 ()


  • Electromyograph

Alpine BioMed - 05704736017091

"Keypoint Focus Notebook System, ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711BV
Not in Commercial Distribution

  • 05704736017091 ()


  • Electromyograph

Alpine BioMed - 05704736017176

"Keypoint Focus Notebook System, ITA Including: - Notebook PC with Keypoint software - Keypoint Focus Main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071106
Not in Commercial Distribution

  • 05704736017176 ()


  • Electromyograph

Alpine BioMed - 05704736017169

"Keypoint Focus Notebook System, NLD Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071105
Not in Commercial Distribution

  • 05704736017169 ()


  • Electromyograph

Alpine BioMed - 05704736017152

"Keypoint Focus Notebook System, SPA Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071104
Not in Commercial Distribution

  • 05704736017152 ()


  • Electromyograph

HarmonyAIR - 00724995192020

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

  • 00724995192020 ()
LG37T

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

HarmonyAIR - 00724995191733

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

  • 00724995191733 ()
LM08

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

HarmonyAIR - 00724995168612

The HarmonyAIR E-Series 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

  • 00724995168612 ()
LEH11

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

HarmonyAIR - 00724995200183

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200183 ()
LAH04INNDTA

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

HarmonyAIR - 00724995200176

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200176 ()
LAH04IN02TA

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

HarmonyAIR - 00724995200169

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200169 ()
LAH04IN01TA

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

HarmonyAIR - 00724995200152

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200152 ()
LAH04NCNDA

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

HarmonyAIR - 00724995200145

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200145 ()
LAH04NC02A

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

HarmonyAIR - 00724995200138

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200138 ()
LAH04NC01A

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

HarmonyAIR - 00724995199944

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199944 ()
LAH24INNDTA

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

HarmonyAIR - 00724995199937

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199937 ()
LAH24IN02TA

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

HarmonyAIR - 00724995199920

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199920 ()
LAH24IN01TA

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

HarmonyAIR - 00724995199913

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199913 ()
LAH24NCNDA

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