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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.
5955-17-06
In Commercial Distribution

  • 00889024208599 ()

  • Size G Minus (G-)
00-5955-017-06

  • Knee femur prosthesis trial, reusable
No Description
Zimmer, Inc.
5955-17-05
In Commercial Distribution

  • 00889024208582 ()

  • Size G Minus (G-)
00-5955-017-05

  • Knee femur prosthesis trial, reusable
No Description
Zimmer, Inc.
5952-17-06
In Commercial Distribution

  • 00889024207905 ()

  • Size G Minus, (G-)
00-5952-017-06

  • Coated knee femur prosthesis
No Description
Zimmer, Inc.
5952-17-05
In Commercial Distribution

  • 00889024207899 ()

  • Size G Minus, (G-)
00-5952-017-05

  • Coated knee femur prosthesis
No Description
Zimmer, Inc.
5950-17-06
In Commercial Distribution

  • 00889024207080 ()

  • Size G Minus, (G-)
00-5950-017-06

  • Uncoated knee femur prosthesis, metallic
No Description
Zimmer, Inc.
5950-17-05
In Commercial Distribution

  • 00889024207073 ()

  • Size G Minus, (G-)
00-5950-017-05

  • Uncoated knee femur prosthesis, metallic
An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8143
Not in Commercial Distribution

  • 00895160002472 ()
  • 10895160002479 ()
MD8143

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-511C-00
In Commercial Distribution

  • 10743816001614 ()
BSP-511C-00

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • Influenza A/B virus antigen IVD, control
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum.
TECO DIAGNOSTICS
ASO-100
In Commercial Distribution

  • 10673486002447 ()
ASO-100

  • Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical
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