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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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ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000
IMRIS Imaging, Inc.
ORT 400 (Trumpf TruSystem 7500 MR) Control Panel Assy
In Commercial Distribution

  • 00857534006509 ()


  • MRI system table, powered
  • Basic diagnostic x-ray system table, powered
Medical Grade HD Flat Panel Monitor, with DVI and HD, 22"
BR Surgical, LLC
BR900-4422
In Commercial Distribution

  • 00857556008505 ()
BR900-4422

  • Image display unit, colour
ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box
GENMARK DIAGNOSTICS, INC.
BCID-GN 12 Kit Box
In Commercial Distribution

  • 00857167005313 ()
EA002012

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
Medical Disposables Corp
MDC-855
In Commercial Distribution

  • 00860007913129 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
Medical Disposables Corp
MDC-855
In Commercial Distribution

  • 00860007913105 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 5 Panel COC150/THC50/AMP500/OPI2000/PCP25
NEXSCREEN, LLC
NCard-05-01
In Commercial Distribution

  • 00858984006286 ()
NCard-05-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Allow connection of the single use sensor to the Panel PC.
EVENTUM ORTHOPAEDICS LTD
CA001
In Commercial Distribution

  • 05065012584233 ()


  • Electrical-only medical device connection cable, reusable
UScreen Oral® Saliva Drug Test Pen, 5 Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSORAL-5NT-EUO
In Commercial Distribution

  • 30850065976281 ()
  • 00850065976280 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cotinine IVD, kit, rapid ICT, clinical
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY, FOREST GREY
Ls Enterprises, Inc.
3386WM-G
In Commercial Distribution

  • D0693386WMG0 ()


  • Dental delivery system
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
UCP BIOSCIENCES, INC.
U-DOA-134
In Commercial Distribution

  • 20817038022126 ()
  • 10817038022129 ()
  • 00817038022122 ()
U-DOA-134

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
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