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

  • 10888277842168 ()
  • 40888277842169 ()
DYNJBIPLR11A

  • General surgical procedure kit, non-medicated, reusable
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
FLSS 40M EX COMF MNT 2PK CD
TARGET CORPORATION
2B8
In Commercial Distribution

  • 00071031812528 ()
  • 80071031812524 ()
  • 10071031812525 ()


  • Dental floss
FLSS 40M INTSE CLN ICY MNT CD
PUBLIX SUPER MARKETS, INC.
2T2
In Commercial Distribution

  • 00041415080720 ()


  • Dental floss
SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
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
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
BD Horizon CD 138 (MI15) APC-R700 ASR
Becton, Dickinson And Company
663995
In Commercial Distribution

  • 00382906639950 ()
663995

  • CD138 cell marker IVD, antibody
BD Horizon CD 123 (9F5) APC-R700 ASR
Becton, Dickinson And Company
663994
In Commercial Distribution

  • 00382906639943 ()
663994

  • Interleukin-3 receptor (IL-3r) IVD, antibody
BD Horizon CD 19 (SJ25C1) BV605 ASR
Becton, Dickinson And Company
663989
In Commercial Distribution

  • 00382906639899 ()
663989

  • CD19 cell marker IVD, antibody
BD Horizon CD 16 (3G8) BV605 ASR
Becton, Dickinson And Company
663988
In Commercial Distribution

  • 00382906639882 ()
663988

  • CD16 cell marker IVD, antibody
BD Horizon CD 123 (9F5) BV421 ASR
Becton, Dickinson And Company
663983
In Commercial Distribution

  • 00382906639837 ()
663983

  • Interleukin-3 receptor (IL-3r) IVD, antibody
BD Horizon CD 117 (104D2) BV421 ASR
Becton, Dickinson And Company
663982
In Commercial Distribution

  • 00382906639820 ()
663982

  • CD117 (c-kit) cell marker IVD, antibody
BD Horizon CD 34 (8G12) BV421 ASR
Becton, Dickinson And Company
663981
In Commercial Distribution

  • 00382906639813 ()
663981

  • CD34 cell marker IVD, antibody
BD Horizon CD 33 (P67.6) BV421 ASR
Becton, Dickinson And Company
663980
In Commercial Distribution

  • 00382906639806 ()
663980

  • CD33 cell marker IVD, antibody
BD Horizon CD 22 (HIB22) BV421 ASR
Becton, Dickinson And Company
663979
In Commercial Distribution

  • 00382906639790 ()
663979

  • CD22 cell marker IVD, antibody
ARCHITECT UIBC-L SI Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-3A
In Commercial Distribution

  • 00380740146689 ()
04R293A

  • Laboratory instrument/analyser application software IVD
ARCHITECT UIBC-L Conv Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-1A
In Commercial Distribution

  • 00380740146672 ()
04R291A

  • Laboratory instrument/analyser application software IVD
"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
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 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
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
Rubella & CMV Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_ V3
Not in Commercial Distribution

  • 00847865003186 ()

  • 1 Each
6653870C

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
EBV IgM Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
6651370C
In Commercial Distribution

  • 00847865002455 ()

  • 1 Each
6651370C

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
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