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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ST. JUDE MEDICAL, INC.
1014940
In Commercial Distribution

  • 05415067036704 ()
1014940

  • Coronary optical coherence tomography system
OPTISm Next DOC
ST. JUDE MEDICAL, INC.
1014939
In Commercial Distribution

  • 05415067036681 ()
1014939

  • Coronary optical coherence tomography system
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-SM
In Commercial Distribution

  • 05415067036667 ()
NVTR-LS-SM

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Loading System
ST. JUDE MEDICAL, INC.
NVTR-LS-LG
In Commercial Distribution

  • 05415067036650 ()
NVTR-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Integrated Next
ST. JUDE MEDICAL, INC.
1014938
In Commercial Distribution

  • 05415067036643 ()
1014938

  • Coronary optical coherence tomography system
PRE-CONNECTED PACK
ST. JUDE MEDICAL, INC.
CMAEK00
In Commercial Distribution

  • 05415067036414 ()
CMAEK00

  • Cardiopulmonary bypass system priming set
  • Cardiopulmonary bypass system centrifugal pump
Delivery Catheter
ST. JUDE MEDICAL, INC.
LSCD111
In Commercial Distribution

  • 05415067036384 ()

  • Outer Diameter: 6.8000 Millimeter
  • Length: 105.0000 Centimeter
LSCD111

  • Vascular guide-catheter, single-use
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800008
In Commercial Distribution

  • 05415067035592 ()
H800008

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800007
In Commercial Distribution

  • 05415067035585 ()
H800007

  • Cardiac catheterization monitoring system
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
ESP200-19
In Commercial Distribution

  • 05415067033116 ()
ESP200-19

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-31M
In Commercial Distribution

  • 05415067033093 ()
E200-31M

  • Mitral open-surgery heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-35S
In Commercial Distribution

  • 05415067032614 ()
TENDV-LP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33M
In Commercial Distribution

  • 05415067032607 ()
TENDV-LP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33S
In Commercial Distribution

  • 05415067032591 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-LP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37L
In Commercial Distribution

  • 05415067032584 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35L
In Commercial Distribution

  • 05415067032577 ()
TENDV-SP-35L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33L
In Commercial Distribution

  • 05415067032560 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-41S
In Commercial Distribution

  • 05415067032553 ()
TENDV-SP-41S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39M
In Commercial Distribution

  • 05415067032546 ()

  • Outer Diameter: 39.0000 Millimeter
TENDV-SP-39M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39S
In Commercial Distribution

  • 05415067032539 ()
TENDV-SP-39S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37M
In Commercial Distribution

  • 05415067032522 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37S
In Commercial Distribution

  • 05415067032515 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35M
In Commercial Distribution

  • 05415067032508 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-SP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35S
In Commercial Distribution

  • 05415067032492 ()
TENDV-SP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33M
In Commercial Distribution

  • 05415067032485 ()
TENDV-SP-33M

  • Mitral transcatheter heart valve bioprosthesis
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-L/R-DDY-CBL
In Commercial Distribution

  • 05415067031808 ()

  • Length: 365.0000 Centimeter
D-ENS-L/R-DDY-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-INQ-OD-CBL
In Commercial Distribution

  • 05415067031792 ()

  • Length: 365.0000 Centimeter
D-ENS-INQ-OD-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-INQ-Q-CBL
In Commercial Distribution

  • 05415067031785 ()

  • Length: 365.0000 Centimeter
D-ENS-INQ-Q-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-SUP-D-CBL
In Commercial Distribution

  • 05415067031778 ()

  • Length: 365.0000 Centimeter
D-ENS-SUP-D-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-SUP-H-CBL
In Commercial Distribution

  • 05415067031761 ()

  • Length: 365.0000 Centimeter
D-ENS-SUP-H-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-SUP-Q-CBL
In Commercial Distribution

  • 05415067031754 ()

  • Length: 365.0000 Centimeter
D-ENS-SUP-Q-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-INQ-DD-CBL
In Commercial Distribution

  • 05415067031747 ()

  • Length: 365.0000 Centimeter
D-ENS-INQ-DD-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-L/R-HOD-CBL
In Commercial Distribution

  • 05415067031730 ()

  • Length: 365.0000 Centimeter
D-ENS-L/R-HOD-CBL

  • Electrical-only medical device connection cable, reusable
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-L/R-BQ-CBL
In Commercial Distribution

  • 05415067031723 ()

  • Length: 365.0000 Centimeter
D-ENS-L/R-BQ-CBL

  • Electrical-only medical device connection cable, reusable
Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-AVSE-6-CBL
In Commercial Distribution

  • 05415067031716 ()
D-ENS-AVSE-6-CBL

  • Electrical-only medical device connection cable, reusable
Catheter Connector Cable
ST. JUDE MEDICAL, INC.
D-ENS-AVSE-5-CBL
In Commercial Distribution

  • 05415067031709 ()
D-ENS-AVSE-5-CBL

  • Electrical-only medical device connection cable, reusable
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVTR-29
In Commercial Distribution

  • 05415067031600 ()

  • Outer Diameter: 29.0000 Millimeter
NVTR-29

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVTR-27
In Commercial Distribution

  • 05415067031594 ()

  • Outer Diameter: 27.0000 Millimeter
NVTR-27

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVTR-25
In Commercial Distribution

  • 05415067031587 ()

  • Outer Diameter: 25.0000 Millimeter
NVTR-25

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVTR-23
In Commercial Distribution

  • 05415067031570 ()

  • Outer Diameter: 23.0000 Millimeter
NVTR-23

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Software Installation
ST. JUDE MEDICAL, INC.
VL Mapping Catheter, Sensor Enabled
In Commercial Distribution

  • 05415067031471 ()
H702520

  • Electrical-only medical device connection adaptor, reusable
Loading System
ST. JUDE MEDICAL, INC.
FNAV-LS-LG
In Commercial Distribution

  • 05415067031440 ()
FNAV-LS-LG

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Loading System
ST. JUDE MEDICAL, INC.
FNAV-LS-SM
In Commercial Distribution

  • 05415067031433 ()
FNAV-LS-SM

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3662
In Commercial Distribution

  • 05415067031426 ()
3662

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
3660
In Commercial Distribution

  • 05415067031419 ()
3660

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
System Reference Electrode
ST. JUDE MEDICAL, INC.
SYS-REF-V1
In Commercial Distribution

  • 05415067031402 ()
SYS-REF-V1

  • Cardiac mapping system reference patch
Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-LG
In Commercial Distribution

  • 05415067031389 ()

  • Catheter Gauge: 19.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-LG

  • Transcatheter heart valve bioprosthesis implantation catheter
Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-SM
In Commercial Distribution

  • 05415067031372 ()

  • Catheter Gauge: 18.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-SM

  • Transcatheter heart valve bioprosthesis implantation catheter
Patient Care System (PCS)
ST. JUDE MEDICAL, INC.
2
In Commercial Distribution

  • 05415067031174 ()
MER3700

  • Multiple active implantable device programmer
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