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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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Bosworth Esteem - H66809215601

Esteem Composite Standard Kit 14 g & 14 g
Harry J Bosworth Company
0921560
Not in Commercial Distribution

  • H66809215601 ()

  • Weight: 14 Gram
0921560

  • Dental composite resin

Trinity Biotech - 05391516747943

FITC Mounting Medium (pH 7.5), 3.0 mL
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution

  • 05391516747943 ()
90-1610

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

HUDSON RCI - 14026704658791

Nebulizer Adaptor 22mm O.D. x 18mm O.D.
TELEFLEX INCORPORATED
IPN029720
In Commercial Distribution

  • 24026704658798 ()
  • 14026704658791 ()
  • 04026704595525 ()
1746

  • Cardiac sizing catheter

HUDSON RCI - 14026704658784

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm O.D.
TELEFLEX INCORPORATED
IPN029719
In Commercial Distribution

  • 24026704658781 ()
  • 14026704658784 ()
  • 04026704595518 ()
1744

  • Cardiac sizing catheter

HUDSON RCI - 14026704658777

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN029718
In Commercial Distribution

  • 24026704658774 ()
  • 14026704658777 ()
  • 04026704595501 ()
1743

  • Cardiac sizing catheter

Rapid Response - 00722066000304

Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Health o meter Professional - 00854896003641

Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical

Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ACCURUN® - 00850041090030

No Description
Lgc Clinical Diagnostics, Inc.
2000-0102
In Commercial Distribution

  • 00850041090030 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090023

No Description
Lgc Clinical Diagnostics, Inc.
2015-0240
In Commercial Distribution

  • 00850041090023 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
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