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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 - 09321502029452

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

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software

Medline Industries, Inc. - 10888277842243

FCP BIPOLAR 7" 1.5 BAY CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR12A
In Commercial Distribution

  • 10888277842243 ()
  • 40888277842244 ()
DYNJBIPLR12A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277842168

FCP BIPOLAR 7 BAY UNCT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR11A
In Commercial Distribution

  • 10888277842168 ()
  • 40888277842169 ()
DYNJBIPLR11A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277841482

FCP BIPOLAR 4.5 NDL UNCT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR03A
In Commercial Distribution

  • 10888277841482 ()
  • 40888277841483 ()
DYNJBIPLR03A

  • General surgical procedure kit, non-medicated, reusable

HIGH DEFINITION LCD MONITOR - 04953170363498

"OEV-262H HIGH DEFINITION LED L CD MONITO"
OLYMPUS MEDICAL SYSTEMS CORP.
OEV262H
In Commercial Distribution

  • 04953170363498 ()


  • Image display unit, colour

BioPlex 2200 - 00847865010993

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

BioPlex 2200 - 00847865010979

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

BioPlex 2200 - 00847865010962

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

BioPlex 2200 - 00847865010948

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

BioPlex 2200 - 00847865010924

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
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