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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™ - 04046964512162

PTSX404 PTSX BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613750
Not in Commercial Distribution

  • 04046964512162 ()
613750

  • Cardiac sizing catheter

PTS-X™ - 04046964512155

PTSX403 PTSX BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613749
In Commercial Distribution

  • 04046964512155 ()
613749

  • Cardiac sizing catheter

PTS-X™ - 04046964512148

PTSX356 PTSX BALLOON 35MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613748
In Commercial Distribution

  • 04046964512148 ()
613748

  • Cardiac sizing catheter

PTS-X™ - 04046964512131

PTSX355 PTSX BALLOON 35MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613747
Not in Commercial Distribution

  • 04046964512131 ()
613747

  • Cardiac sizing catheter

PTS-X™ - 04046964512124

PTSX354 PTSX BALLOON 35MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613746
In Commercial Distribution

  • 04046964512124 ()
613746

  • Cardiac sizing catheter

PTS-X™ - 04046964512100

PTSX305 PTSX BALLOON 30MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613744
In Commercial Distribution

  • 04046964512100 ()
613744

  • Cardiac sizing catheter

PTS-X™ - 04046964512087

PTSX303 PTSX BALLOON 30MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613742
In Commercial Distribution

  • 04046964512087 ()
613742

  • Cardiac sizing catheter

PTS-X™ - 04046964512063

PTSX253 PTSX BALLOON 25MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613740
In Commercial Distribution

  • 04046964512063 ()
613740

  • Cardiac sizing catheter

PTS-X™ - 04046964512049

PTSX203 PTSX BALLOON 20MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613738
In Commercial Distribution

  • 04046964512049 ()
613738

  • Cardiac sizing catheter

PTS® - 04046964310997

PTS305 PTS BALLOON 30MM X 5CM X 80 CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613704
In Commercial Distribution

  • 04046964310997 ()
613704

  • Cardiac sizing catheter
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