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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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McKesson - 00612479202719

TEST KIT, H PYLORI (10/KT)
MCKESSON MEDICAL-SURGICAL INC.
5007
In Commercial Distribution

  • 00612479240087 ()
  • 00612479202719 ()


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

McKesson - 00612479202702

TEST KIT, H PYLORI (25/KT)
MCKESSON MEDICAL-SURGICAL INC.
5008
In Commercial Distribution

  • 00612479240070 ()
  • 00612479202702 ()


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

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

ACCURUN® - 00850041090016

No Description
Lgc Clinical Diagnostics, Inc.
2010-0023
In Commercial Distribution

  • 00850041090016 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090009

No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

Health o meter Professional - 00854896003641

Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical

Universal Cannula - 05051223003984

The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3506
In Commercial Distribution

  • 50551223003989 ()
  • 35051223003985 ()
  • 05051223003984 ()

  • 12mm diameter x 100mm length
PS3506

  • Cardiac sizing catheter

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)

Tissue-Tek® Accu-Edge® - 00615233012753

Scale, Digital
SAKURA FINETEK U.S.A., INC.
0204
In Commercial Distribution

  • 00615233012753 ()
0204

  • Laboratory scale, electronic
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