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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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Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


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

Health o meter professional - 00892076002312

Mechanical Dial Scale
Pelstar, LLC
386KGS-01
In Commercial Distribution

  • 00892076002312 ()


  • Laboratory scale, mechanical

Health o meter professional - 00892076002305

Mechanical Dial Scale
Pelstar, LLC
386S01
In Commercial Distribution

  • 00892076002305 ()


  • Laboratory scale, mechanical

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™ - 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™ - 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™ - 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™ - 04046955677368

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

  • 04046955677368 ()
613723

  • Cardiac sizing catheter
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