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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™ - 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™ - 04046964512094

PTSX304 PTSX BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613743
In Commercial Distribution

  • 04046964512094 ()
613743

  • 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™ - 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™ - 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™ - 04046964512056

PTSX204 PTSX BALLOON 20MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613739
In Commercial Distribution

  • 04046964512056 ()
613739

  • 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™ - 04046964512032

PTSX154 PTSX BALLOON 15MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613737
Not in Commercial Distribution

  • 04046964512032 ()
613737

  • 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™ - 04046964512018

PTSX152 PTSX BALLOON 15MM X 2CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613735
Not in Commercial Distribution

  • 04046964512018 ()
613735

  • 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

PTS-X™ - 04046964511998

PTSX122 PTSX BALLOON 12MM X 2CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613733
Not in Commercial Distribution

  • 04046964511998 ()
613733

  • Cardiac sizing catheter

PTS-X™ - 04046964511981

PTSX103 PTSX BALLOON 10MM X 3 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613732
In Commercial Distribution

  • 04046964511981 ()
613732

  • Cardiac sizing catheter

PTS-X™ - 04046964511974

PTSX102 PTSX BALLOON 10MM X 2 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613731
Not in Commercial Distribution

  • 04046964511974 ()
613731

  • Cardiac sizing catheter

PTS-X™ - 04046964511967

PTSX101 PTSX BALLOON 10MM X 1 CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613730
Not in Commercial Distribution

  • 04046964511967 ()
613730

  • Cardiac sizing catheter

PTS® - 04046964311055

PTS405 PTS BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613707
In Commercial Distribution

  • 04046964311055 ()
613707

  • Cardiac sizing catheter

PTS® - 04046964311031

PTS404 PTS BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613706
In Commercial Distribution

  • 04046964311031 ()
613706

  • Cardiac sizing catheter

PTS® - 04046964311017

PTS403 PTS BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613705
In Commercial Distribution

  • 04046964311017 ()
613705

  • 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

PTS® - 04046964310973

PTS304 PTS BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613703
In Commercial Distribution

  • 04046964310973 ()
613703

  • Cardiac sizing catheter
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