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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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IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571
In Commercial Distribution

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • Peripheral intravenous catheterization support kit
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2591
In Commercial Distribution

  • 00653160360462 ()
  • 10653160360469 ()
DYNDV2591

  • Peripheral intravenous catheterization support kit
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate
LARGE VESS APP 15MM TAPERED BLADES
TELEFLEX INCORPORATED
IPN002336
In Commercial Distribution

  • 04026704507108 ()
  • 24026704507102 ()

  • Length: 1.625 Inch
  • Width: 1 Inch
065196

  • Surgical bulldog clamp, reusable
LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software
Omnipod Display is secondary display app
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile.
Terarecon Inc.
iNtuitionEMV
In Commercial Distribution

  • INTUITION4 ()


  • Radiological PACS software
No Description
NOVODIAX, INC.
C30005-015ML
In Commercial Distribution

  • 00850030934956 ()

  • Total Volume: 15 Milliliter


  • Immunohistochemistry conjugated secondary antibody IVD
No Description
NOVODIAX, INC.
C30005-010ML
In Commercial Distribution

  • 00850030934949 ()

  • Total Volume: 10 Milliliter


  • Immunohistochemistry conjugated secondary antibody IVD
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