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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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PTS-X™ - 04046955677306

PTSX307 PTS-X BALLOON 30MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613720
In Commercial Distribution

  • 04046955677306 ()
613720

  • Cardiac sizing catheter

PTS-X™ - 04046955677283

PTSX306 PTS-X BALLOON 30MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613719
In Commercial Distribution

  • 04046955677283 ()
613719

  • Cardiac sizing catheter

PTS-X™ - 04046955677269

PTSX255 PTS-X BALLOON 25MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613718
In Commercial Distribution

  • 04046955677269 ()
613718

  • Cardiac sizing catheter

PTS-X™ - 04046955677245

PTSX206 PTS-X BALLOON 20MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613717
In Commercial Distribution

  • 04046955677245 ()
613717

  • Cardiac sizing catheter

PTS-X™ - 04046955677221

PTSX205 PTS-X BALLOON 20MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613716
In Commercial Distribution

  • 04046955677221 ()
613716

  • Cardiac sizing catheter

Signify® - 10815845020079

No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution

  • 10815845020079 ()
  • 00815845020072 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Clearview® - 10815845020048

No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Detector H. pylori - 10722355002023

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Detector H. pylori - 10722355002016

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Rapid Response - 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
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