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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ABDOMINAL BINDER 9IN 3 PANEL XXL(63IN- 75IN)
TETRA MEDICAL SUPPLY CORP.
260005
In Commercial Distribution

  • 00614138154469 ()
260005

  • Abdominal binder, reusable
ABDOMINAL BINDER 9IN 3 PANEL XL (46IN- 62IN)
TETRA MEDICAL SUPPLY CORP.
260004
In Commercial Distribution

  • 00614138025387 ()
260004

  • Abdominal binder, reusable
ABDOMINAL BINDER 9IN 3 PANEL REG(30IN- 45IN)
TETRA MEDICAL SUPPLY CORP.
260000
In Commercial Distribution

  • 00614138025370 ()
260000

  • Abdominal binder, reusable
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC
In Commercial Distribution

  • D0692520MCC0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL
Ls Enterprises, Inc.
2186
In Commercial Distribution

  • D06921860 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL
Ls Enterprises, Inc.
2184
In Commercial Distribution

  • D06921840 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 2 HP AUTO, MCC
Ls Enterprises, Inc.
2520MCC-G
In Commercial Distribution

  • D0692520MCCG0 ()


  • Dental delivery system
ATLAS Stim Headbox with High Density side panel.
NEURALYNX, INC.
High Density
In Commercial Distribution

  • 00850011306345 ()
31-0601-0132

  • Somatosensory electrical stimulation system
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY S E
In Commercial Distribution

  • 04547410436983 ()


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY E
In Commercial Distribution

  • 04547410426922 ()


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1270 SE BATTERY E
In Commercial Distribution

  • 04547410355420 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1305SE incorporates a GOS indirect panel.
FUJIFILM CORPORATION
DR-ID 1305 SE E
In Commercial Distribution

  • 04547410322927 ()

  • 567.4x1339.8x50mm


  • Stationary basic diagnostic x-ray system, digital
Transportable Medical Equipment stand for the Panel PC
EVENTUM ORTHOPAEDICS LTD
TR001
In Commercial Distribution

  • 05065012584523 ()


  • Transportable medical equipment stand, non-powered
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712228
In Commercial Distribution

  • 00884838085695 ()
712228

  • Stationary basic diagnostic x-ray system, digital
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712227
In Commercial Distribution

  • 00884838085688 ()
712227

  • Stationary basic diagnostic x-ray system, digital
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712226
In Commercial Distribution

  • 00884838085671 ()
712226

  • Stationary basic diagnostic x-ray system, digital
CLIA Waived Drug Test Dip - 1 Panel BUP10
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000126 ()
VC-D01-BUP10-37

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Dip - 1 Panel OXY100
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000089 ()
VC-D01-OXY100-37

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Dip - 1 Panel THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000034 ()
VC-D01-THC50-37

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)
IDUN SOLUTIONS LLC
IDOA-3105
Not in Commercial Distribution

  • 00857275007261 ()
  • 00857275007186 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific 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
eSensor® Respiratory Viral Panel Reagent (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005139 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Amplification Reagents (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005115 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Cartridges (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005108 ()
MT005100

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
CLIA Waived 7 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY-BUP)
Medical Disposables Corp
M-DOA-375
In Commercial Distribution

  • 00851721007799 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-TCA)
Medical Disposables Corp
M-DOA-1104
In Commercial Distribution

  • 00851721007478 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-MDMA-OXY-PPX)
Medical Disposables Corp
M-DOA-1124
In Commercial Distribution

  • 00851721007461 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 3 Panel Drug Test Card-(THC-COC-OPI)
Medical Disposables Corp
M-DOA-134
In Commercial Distribution

  • 00851721007454 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 4 Panel Drug Test Card-(THC-COC-OPI-MET)
Medical Disposables Corp
M-DOA-144
In Commercial Distribution

  • 00851721007447 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-PCP)
Medical Disposables Corp
M-DOA-154
In Commercial Distribution

  • 00851721007430 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP)
Medical Disposables Corp
M-DOA-164
In Commercial Distribution

  • 00851721007423 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 3 Panel Drug Test Card-(THC-COC-MET)
Medical Disposables Corp
M-DOA-234
In Commercial Distribution

  • 00851721007416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 4 Panel Drug Test Card-(THC-COC-OPI-AMP)
Medical Disposables Corp
M-DOA-244
In Commercial Distribution

  • 00851721007409 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-MET)
Medical Disposables Corp
M-DOA-254
In Commercial Distribution

  • 00851721007393 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-BZO)
Medical Disposables Corp
M-DOA-264
In Commercial Distribution

  • 00851721007386 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 7 Panel Drug Test Card-(THC-COC-OPI-MET-BZO-OXY-AMP)
Medical Disposables Corp
M-DOA-274
In Commercial Distribution

  • 00851721007379 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-MDMA)
Medical Disposables Corp
M-DOA-3104
In Commercial Distribution

  • 00851721007362 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Card-(THC-COC-OPI-AMP-BAR-BZO-MTD-MDMA-PCP-OXY-TCA-BUP)
Medical Disposables Corp
M-DOA-3124
In Commercial Distribution

  • 00851721007355 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-MET-OXY)
Medical Disposables Corp
M-DOA-354
In Commercial Distribution

  • 00851721007348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-OXY)
Medical Disposables Corp
M-DOA-4104
In Commercial Distribution

  • 00851721007331 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-MET-MDMA)
Medical Disposables Corp
M-DOA-554
In Commercial Distribution

  • 00851721007324 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-MET-BZO-OXY)
Medical Disposables Corp
M-DOA-564
In Commercial Distribution

  • 00851721007317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-MET-MTD-AMP-OXY-BAR-BZO-BUP)
Medical Disposables Corp
M-DOA-6104
In Commercial Distribution

  • 00851721007300 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Card-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-MDMA-MTD-OXY-BUP)
Medical Disposables Corp
M-DOA-6125
In Commercial Distribution

  • 00851721007294 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-MET-BZO)
Medical Disposables Corp
M-DOA-654
In Commercial Distribution

  • 00851721007287 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-BZO-MET-TCA-OXY-BUP-BAR-MTD)
Medical Disposables Corp
M-DOA-7104
In Commercial Distribution

  • 00851721007270 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-BZO)
Medical Disposables Corp
M-DOA-754
In Commercial Distribution

  • 00851721007263 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-BZO)
Medical Disposables Corp
M-DOA-754
In Commercial Distribution

  • 00851721007157 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 10 Panel Drug Test Card-(THC-COC-OPI-BZO-MET-TCA-OXY-BUP-BAR-MTD)
Medical Disposables Corp
M-DOA-7104
In Commercial Distribution

  • 00851721007140 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-MET-BZO)
Medical Disposables Corp
M-DOA-654
In Commercial Distribution

  • 00851721007133 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Card-(THC-COC-MOP-AMP-MET-PCP-BZO-BAR-MDMA-MTD-OXY-BUP)
Medical Disposables Corp
M-DOA-6125
In Commercial Distribution

  • 00851721007126 ()


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