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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™ - 04046964512179

PTSX405 PTSX BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613751
In Commercial Distribution

  • 04046964512179 ()
613751

  • 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™ - 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™ - 04046964512117

PTSX353 PTSX BALLOON 35MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613745
Not in Commercial Distribution

  • 04046964512117 ()
613745

  • 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™ - 04046964512070

PTSX254 PTSX BALLOON 25MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613741
Not in Commercial Distribution

  • 04046964512070 ()
613741

  • 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-X™ - 04046964512025

PTSX153 PTSX BALLOON 15MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613736
In Commercial Distribution

  • 04046964512025 ()
613736

  • Cardiac sizing catheter

PTS-X™ - 04046964512001

PTSX123 PTSX BALLOON 12MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613734
Not in Commercial Distribution

  • 04046964512001 ()
613734

  • Cardiac sizing catheter
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