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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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NexGen® - 00889024259706

No Description
Zimmer, Inc.
65-5952-17-05
In Commercial Distribution

  • 00889024259706 ()

  • Size G Minus, (G-)
65-5952-017-05

  • Coated knee femur prosthesis

Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System - B110CM20120

No Description
Bion Enterprises, Ltd.
CM-2012
In Commercial Distribution

  • B110CM20120 ()
CM-2012

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, reagent

Argyle - 10884527007073

CPAP Nasal Cannula,Babies 1000 g - 1500 g
Cardinal Health, Inc.
8888162016
In Commercial Distribution

  • 20884527007070 ()
  • 10884527007073 ()

  • Clothing Size,Small,N/A;
8888162016

  • Nasal oxygen cannula, CPAP

Bosworth Esteem - H66809215601

Esteem Composite Standard Kit 14 g & 14 g
Harry J Bosworth Company
0921560
Not in Commercial Distribution

  • H66809215601 ()

  • Weight: 14 Gram
0921560

  • Dental composite resin

Trinity Biotech - 05391516747943

FITC Mounting Medium (pH 7.5), 3.0 mL
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution

  • 05391516747943 ()
90-1610

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

PTS-X™ - 04046955677405

PTSX409 PTS-X BALLOON 40MM X 5CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613725
In Commercial Distribution

  • 04046955677405 ()
613725

  • Cardiac sizing catheter

PTS-X™ - 04046955677382

PTSX407 PTS-X BALLOON 40MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613724
In Commercial Distribution

  • 04046955677382 ()
613724

  • Cardiac sizing catheter

PTS-X™ - 04046955677368

PTSX360 PTS-X BALLOON 35MM X 6CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613723
In Commercial Distribution

  • 04046955677368 ()
613723

  • Cardiac sizing catheter

PTS-X™ - 04046955677344

PTSX358 PTS-X BALLOON 35MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613722
In Commercial Distribution

  • 04046955677344 ()
613722

  • Cardiac sizing catheter
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