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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™ - 04046955677344

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

  • 04046955677344 ()
613722

  • Cardiac sizing catheter

PTS-X™ - 04046955677320

PTSX308 PTS-X BALLOON 30MM X 5CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613721
In Commercial Distribution

  • 04046955677320 ()
613721

  • Cardiac sizing catheter

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

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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