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 CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177747
In Commercial Distribution

  • 20758750034830 ()
  • 10758750034833 ()
6177747

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802241
In Commercial Distribution

  • 10758750002351 ()
  • 20758750002358 ()
6802241

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800034
In Commercial Distribution

  • 10758750000548 ()
  • 20758750000545 ()
6800034

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
E-Type K-Style CA 1:1 Latch Chuck
SIRONA Dental Systems GmbH
710430
In Commercial Distribution

  • E2767104300 ()


  • Dental power tool handpiece motorless component
EASY MOUNTER PREMIUM ONE CA, SLEEVE 550
SWEDEN & MARTINA SPA
GS-EASY-AS-550-CA
In Commercial Distribution

  • D7701515563 ()
GS-EASY-AS-550-CA

  • Surgical screwdriver, reusable
EASY MOUNTER PREMIUM ONE CA, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASY-AS-415-CA
In Commercial Distribution

  • D7701515553 ()
GS-EASY-AS-415-CA

  • Surgical screwdriver, reusable
PrimePlus Bariatric Bed, 750 lb. Wgt Ca
Drive Devilbiss Healthcare
P1752
Not in Commercial Distribution

  • 00822383550626 ()


  • Bariatric bed
EasyLyte Na/K/Cl/Ca/Li Analyzer
MEDICA CORPORATION
2030
In Commercial Distribution

  • 00386100002930 ()
2030

  • Ion-selective analyser IVD
EasyLyte Calcium Na/K/Ca/pH Analyzer
MEDICA CORPORATION
2016
In Commercial Distribution

  • 00386100002893 ()
2016

  • Ion-selective analyser IVD
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