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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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Trinity Biotech - 05391516747806

Cardiac Positive Control, 0.5 mL
MARDX DIAGNOSTICS, INC.
10-5402
In Commercial Distribution

  • 05391516747806 ()
10-5402

  • Multiple cardiac marker IVD, control

Trinity Biotech - 05391516747790

Monkey Heart 4 Well Slides, 12 each/pack
MARDX DIAGNOSTICS, INC.
10-5404
In Commercial Distribution

  • 05391516747790 ()
10-5404

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747783

Anti Cardiac Antibody IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
10-5448
In Commercial Distribution

  • 05391516747783 ()
10-5448

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay

POLY Pro - B3437000A3

LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrared Light or Combo Red/Infrared Light to provide a feeling of General Wellness.
Medtek Lighting Corporation
Regen
In Commercial Distribution

  • B3437000A3 ()


  • Blue/red/infrared phototherapy lamp

The Tether™ - 03662663080842

Tether Tension Indicator
Highridge Medical, LLC
240H6004
In Commercial Distribution

  • 03662663080842 ()
240H6004

  • Anterior spinal tethering system tether

The Tether™ - 03662663080835

Tether Reel Tensioner
Highridge Medical, LLC
240H6003
In Commercial Distribution

  • 03662663080835 ()
240H6003

  • Anterior spinal tethering system tether

Denture, Restoration - 08936214221202

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
120
In Commercial Distribution

  • 08936214221219 ()
  • 08936214221202 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Denture, restoration - 06972677871327

No Description
Modern Dental Laboratory (DG) Co., Ltd.
132
In Commercial Distribution

  • 06972677871334 ()
  • 06972677871327 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

BioFire® Respiratory Panel 2.1 EUA - 00815381020482

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests - 00815381020239

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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