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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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No Description
Zimmer, Inc.
65-5952-17-06
In Commercial Distribution

  • 00889024259713 ()

  • Size G Minus, (G-)
65-5952-017-06

  • Coated knee femur prosthesis
No Description
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
No Description
INBIOS INTERNATIONAL, INC
COVG-RE
In Commercial Distribution

  • B379COVGRE1 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
No Description
Bion Enterprises, Ltd.
CM-2012
In Commercial Distribution

  • B110CM20120 ()
CM-2012

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, reagent
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
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
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
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