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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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199975
In Commercial Distribution

  • 10758750034567 ()
6199975

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199960
In Commercial Distribution

  • 10758750034413 ()
6199960

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199949
In Commercial Distribution

  • 10758750033584 ()
6199949

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
Auto Reader IV
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902093
In Commercial Distribution

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated
Open-End Flexi-Tip, Ureteral Catheter
COOK INCORPORATED
G17915
Not in Commercial Distribution

  • 00827002179158 ()
021304-120

  • Ureteral catheter
Open-End Ureteral Catheter
COOK INCORPORATED
G17819
Not in Commercial Distribution

  • 00827002178199 ()
020040-C7

  • Ureteral catheter
Whistle Tip Ureteral Catheter (Left)
COOK INCORPORATED
G17262
Not in Commercial Distribution

  • 00827002172623 ()
022204-NOSP

  • Ureteral catheter
Round Tip Ureteral Catheter (Left)
COOK INCORPORATED
G17237
Not in Commercial Distribution

  • 00827002172371 ()
024205-110

  • Ureteral catheter
Open-End Ureteral Catheter
COOK INCORPORATED
G17160
Not in Commercial Distribution

  • 00827002171602 ()
020040-PS-6

  • Ureteral catheter
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