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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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Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, X-Large
STANDARD TEXTILE CO., INC.
75674914
In Commercial Distribution

  • 10634916797166 ()
  • 00634916797169 ()


  • Surgical gown, reusable
Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Large
STANDARD TEXTILE CO., INC.
75674915
In Commercial Distribution

  • 10634916797159 ()
  • 00634916797152 ()


  • Surgical gown, reusable
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ; Adulterants: +pH, OX,SG
MERCEDES MEDICAL, LLC
TNR CDOA5125A3
In Commercial Distribution

  • 00850011007075 ()
  • 10850011007072 ()
  • 20850011007079 ()
TNR CDOA5125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • 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
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D12.2-1P29-25
In Commercial Distribution

  • 00722066003688 ()
  • 00722066004074 ()
D12.2-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR E-Series Dual Flat Panel Monitor ARM, 67-inch ARM 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

  • 00724995168674 ()
LES57

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

  • 00724995168650 ()
LES56

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR E-Series Single Light 35-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

  • 00724995168421 ()
LES04

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Dual Spindle Light Head with Video 1750mm Single Flat Panel Monitor 1600mm G-Series 11008906 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
In Commercial Distribution

  • 00724995170479 ()
LK00015

  • Medical monitor/light mount
The HarmonyAIR E-Series 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

  • 00724995168407 ()
LES24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Single Light, Camera Hybrid, Single Flat Panel Monitor, Single Cardanic and Spring Arm is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167219 ()
LGH25N

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