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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 - 00724995165659

The Single M5 without Control with Single M5 with Single Flat Panel Monitor, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165659 ()
LM04NT

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

HarmonyAIR - 00724995176198

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, No Drop Tube, No Camera, Tandem is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176198 ()
LES57NCNDT

  • Medical monitor/light mount

HarmonyAIR - 00724995176181

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176181 ()
LES57NC02T

  • Medical monitor/light mount

HarmonyAIR - 00724995176174

The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176174 ()
LES57NC01T

  • Medical monitor/light mount

HarmonyAIR - 00724995200985

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

  • 00724995200985 ()
LAH14NC02T

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

HarmonyAIR - 00724995214371

The E-Series 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

  • 00724995214371 ()
LES14NC02T

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

HarmonyAIR - 00724995214364

The E-Series 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

  • 00724995214364 ()
LES14NC01T

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

HarmonyAIR - 00724995214227

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214227 ()
LEH14IN02T

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

HarmonyAIR - 00724995214388

The E-Series 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

  • 00724995214388 ()
LES14NCNDT

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

HarmonyAIR - 00724995214234

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

  • 00724995214234 ()
LEH14INNDT

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

HarmonyAIR - 00724995214210

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214210 ()
LEH14IN01T

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

HarmonyAIR - 00724995214111

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

  • 00724995214111 ()
LES31NCND

  • Medical monitor/light mount

HarmonyAIR - 00724995214104

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

  • 00724995214104 ()
LES31NC02

  • Medical monitor/light mount

HarmonyAIR - 00724995214098

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

  • 00724995214098 ()
LES31NC01

  • Medical monitor/light mount

REF - 00850798007725

SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, BZO, COC, mAMP, OPI, THC, 25/BX
TRANSMED CO, LLC
REF-EWCUP-264
In Commercial Distribution

  • 00850798007749 ()
  • 00850798007732 ()
  • 00850798007725 ()


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

Alpine BioMed - 05704736019477

"Keypoint Focus Module: CN Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701CN
Not in Commercial Distribution

  • 05704736019477 ()


  • Electromyograph

Status ASSURE - 00868348000232

MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA2K
In Commercial Distribution

  • 00868348000232 ()
71125AA2K

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

Status ASSURE - 00868348000225

MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Cup
Lifesign L.L.C.
71125AA
In Commercial Distribution

  • 00868348000225 ()
71125AA

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

Status ASSURE - 00868348000218

(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA2K
In Commercial Distribution

  • 00868348000218 ()
11125AA2K

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

Status ASSURE - 00868348000201

(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card
Lifesign L.L.C.
11125AA
In Commercial Distribution

  • 00868348000201 ()
11125AA

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

HarmonyAIR - 00724995199401

The A-Series High Definition Dual Light, 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

  • 00724995199401 ()
LAH02INNDA

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

HarmonyAIR - 00724995199395

The A-Series High Definition Dual Light, 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

  • 00724995199395 ()
LAH02IN02A

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

HarmonyAIR - 00724995199388

The A-Series High Definition Dual Light, 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

  • 00724995199388 ()
LAH02IN01A

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

HarmonyAIR - 00724995192334

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

  • 00724995192334 ()
LGH14CP

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

HarmonyAIR - 00724995192273

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

  • 00724995192273 ()
LGH08

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

HarmonyAIR - 00724995192129

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

  • 00724995192129 ()
LG11T

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

HarmonyAIR - 00724995191818

The M7/M5 High Density Package, Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191818 ()
LMH08

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

HarmonyAIR - 00724995191771

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

  • 00724995191771 ()
LMH29

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

HarmonyAIR - 00724995191764

The M7 Single High Density Package, No Hub, 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

  • 00724995191764 ()
LMH09T

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

HarmonyAIR - 00724995191696

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

  • 00724995191696 ()
LM29

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