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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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EASY MOUNTER - D7701515623

EASY MOUNTER PRAMA CA, POST EXTRACT, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASYPE-L-415-CA
In Commercial Distribution

  • D7701515623 ()
GS-EASYPE-L-415-CA

  • Surgical screwdriver, reusable

VITROS - 10758750034826

VITROS Immunodiagnostic Products CA 125 II Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177746
In Commercial Distribution

  • 10758750034826 ()
6177746

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002368

VITROS Immunodiagnostic Products CA 19-9™ Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802242
In Commercial Distribution

  • 10758750002368 ()
  • 20758750002365 ()
6802242

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001316

VITROS Immunodiagnostic Products CA 125 II Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801757
In Commercial Distribution

  • 10758750001316 ()
6801757

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750000999

VITROS Immunodiagnostic Products CA 15-3™ Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6800879
In Commercial Distribution

  • 10758750000999 ()
  • 20758750000996 ()
6800879

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

OC-Auto - 00816917026107

Personal Use Kit OC-Auto, for VA Livermore, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 918369
In Commercial Distribution

  • 00816917026107 ()


  • Faecal occult blood IVD, reagent

OC-Auto - 00816917022024

Personal Use Kit OC-Auto, for San Diego, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334351
In Commercial Distribution

  • 00816917022024 ()


  • Faecal occult blood IVD, reagent

OC-Auto - 00816917021973

Personal Use Kit OC-Auto, for Palo Alto, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334272
In Commercial Distribution

  • 00816917021973 ()


  • Faecal occult blood IVD, reagent

OC-Auto - 00816917021898

Personal Use Kit OC-Auto, for Loma Linda, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2333714
In Commercial Distribution

  • 00816917021898 ()


  • Faecal occult blood IVD, reagent

OC-Auto - 00816917021713

Personal Use Kit OC-Auto, for Long Beach, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 220104
In Commercial Distribution

  • 00816917021713 ()


  • Faecal occult blood IVD, reagent
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