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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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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

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH - 09321502029599

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software

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

MEDI - 00636257025888

PROFILE ARM BLACK W/O GAUNTLET C-D
MEDI MANUFACTURING, INC.
CFAMSC53
In Commercial Distribution

  • 00636257025888 ()


  • Compression bandaging kit

Medtronic Reusable Instruments - 00673978062389

INSTRUMENT 85626 CD RED PED PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85626
In Commercial Distribution

  • 00673978062389 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978062372

INSTRUMENT 85621 CD RED TRNS PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85621
In Commercial Distribution

  • 00673978062372 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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