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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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The Touch Panel Control Unit Primary Dual Remote Power Module Set M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
Not in Commercial Distribution

  • 00724995165574 ()
LM0011

  • Medical monitor/light mount
Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
OMEGA MEDICAL IMAGING, LLC
Soteria.AI
In Commercial Distribution

  • 00853901007025 ()


  • Stationary angiographic x-ray system, digital
CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-265
In Commercial Distribution

  • 00850798007633 ()
  • 00850798007640 ()
  • 00850798007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-6MB
Not in Commercial Distribution

  • 00858998006159 ()
USSCupA-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The E-Series 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

  • 00724995214357 ()
LES14INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The E-Series 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

  • 00724995214340 ()
LES14IN02T

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The E-Series 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

  • 00724995214333 ()
LES14IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
HarmonyAIR A-Series High Density Single Adjustable Light 43-inch, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203115 ()
LAH24A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
A-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201111 ()
LAS14NCNDT

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

  • 00724995201104 ()
LAS14NC02T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201098 ()
LAS14NC01T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, No Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200909 ()
LAH14INND

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200893 ()
LAH14IN02

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200886 ()
LAH14IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200848 ()
LAS31NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200831 ()
LAS31NC02

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200824 ()
LAS31NC01

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA2135
In Commercial Distribution

  • 00850011007105 ()
  • 10850011007102 ()
  • 20850011007109 ()
TNR CDOA2135

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA
MERCEDES MEDICAL, LLC
TNR MMC12MOP
In Commercial Distribution

  • 00850011007099 ()
  • 10850011007096 ()
  • 20850011007093 ()
TNR MMC12MOP

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent
T2 BIOSYSTEMS, INC.
90-11400
In Commercial Distribution

  • M70890114000 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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