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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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Zimmer, Inc.
65-5952-17-05
In Commercial Distribution

  • 00889024259706 ()

  • Size G Minus, (G-)
65-5952-017-05

  • Coated knee femur prosthesis
A in vitro diagnostic test for the qualitative detection of IgG antibody against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8146
In Commercial Distribution

  • 10895160002721 ()
  • 00895160002724 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
CPAP Nasal Cannula,Babies 1000 g - 1500 g
Cardinal Health, Inc.
8888162016
In Commercial Distribution

  • 20884527007070 ()
  • 10884527007073 ()

  • Clothing Size,Small,N/A;
8888162016

  • Nasal oxygen cannula, CPAP
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
Nebulizer Adaptor 22mm O.D. x 18mm O.D.
TELEFLEX INCORPORATED
IPN029720
In Commercial Distribution

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

  • Cardiac sizing catheter
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
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 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
Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical
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)
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