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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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CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software
syngo Dynamics VA20F Workplace Installer CD Label
Siemens Healthcare GmbH
10745438
In Commercial Distribution

  • 04056869227047 ()


  • Radiological PACS software
Celiac IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010580 ()

  • 1 Each
6652370A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
"OEV-262H HIGH DEFINITION LED L CD MONITO"
OLYMPUS MEDICAL SYSTEMS CORP.
OEV262H
In Commercial Distribution

  • 04953170363498 ()


  • Image display unit, colour
HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865010993 ()

  • 1 Each
6653370E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
MMRV IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010979 ()

  • 1 Each
6652470D

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Celiac IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1v1
In Commercial Distribution

  • 00847865010962 ()

  • 1 Each
6652270B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
ToRC IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010948 ()

  • 1 Each
6651670H

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Syphilis IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865010924 ()

  • 1 Each
6651470E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Celiac IgG Assay Protocol file CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010573 ()

  • 1 Each
6652270A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
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