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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Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29M
In Commercial Distribution

  • 05415067033086 ()
E200-29M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29A
In Commercial Distribution

  • 05415067033079 ()
E200-29A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27M
In Commercial Distribution

  • 05415067033062 ()
E200-27M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27A
In Commercial Distribution

  • 05415067033055 ()
E200-27A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25M
In Commercial Distribution

  • 05415067033048 ()
E200-25M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25A
In Commercial Distribution

  • 05415067033031 ()
E200-25A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-23A
In Commercial Distribution

  • 05415067033024 ()
E200-23A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-21A
In Commercial Distribution

  • 05415067033017 ()
E200-21A

  • Aortic open-surgery heart valve bioprosthesis
HF Cardiac Resychronisation Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA300Q
In Commercial Distribution

  • 05415067032850 ()
CDHFA300Q

  • Cardiac resynchronization therapy implantable defibrillator
DR Implantable Cardioverter Defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
CDDRA300Q
In Commercial Distribution

  • 05415067032843 ()
CDDRA300Q

  • Dual-chamber implantable defibrillator
VR Implantable Cardioverter Defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CDVRA300Q
In Commercial Distribution

  • 05415067032836 ()
CDVRA300Q

  • Single-chamber implantable defibrillator
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
Mobile application compatible to Android operating system
ST. JUDE MEDICAL, INC.
APP1004
In Commercial Distribution

  • 05415067032812 ()
APP1004

  • Implantable cardiac device management application software
X EP System Surface Electrode Kit
ST. JUDE MEDICAL, INC.
ENSITE-SEK-5-01
In Commercial Distribution

  • 05415067032379 ()
  • 15415067032376 ()
ENSITE-SEK-5-01

  • Cardiac mapping system reference patch
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
PRCN-SEK-A
In Commercial Distribution

  • 05415067032355 ()
  • 15415067032352 ()
PRCN-SEK-A

  • Cardiac mapping system reference patch
Locating Electrodes
ST. JUDE MEDICAL, INC.
SURF-ELEC-2PRS
In Commercial Distribution

  • 05415067032300 ()
SURF-ELEC-2PRS

  • Cardiac mapping system reference patch
Steerable Catheter with Electrodes
ST. JUDE MEDICAL, INC.
DS3H010-38
In Commercial Distribution

  • 05415067032287 ()

  • Catheter Gauge: 10.5000 French
DS3H010-38

  • Vascular guide-catheter, single-use
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-CF-01
In Commercial Distribution

  • 05415067032256 ()
ENSITE-D-CF-01

  • Cardiac mapping system application software
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-CF-01
In Commercial Distribution

  • 05415067032249 ()
ENSITE-CF-01

  • Cardiac mapping system application software
Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-4.5C-01
In Commercial Distribution

  • 05415067032232 ()
ENSITE-FF-4.5C-01

  • Electrical-only medical device connection cable, reusable
Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-3MC-01
In Commercial Distribution

  • 05415067032225 ()
ENSITE-FF-3MC-01

  • Electrical-only medical device connection cable, reusable
Amplifier Power Module
ST. JUDE MEDICAL, INC.
ENSITE-AMP-EPM-01
In Commercial Distribution

  • 05415067032218 ()
ENSITE-AMP-EPM-01

  • Electrical-only medical device connection cable, reusable
X EP System Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-R-FF-01
In Commercial Distribution

  • 05415067032201 ()
ENSITE-R-FF-01

  • Electromagnetic surgical navigation device tracking system
Field Frame
ST. JUDE MEDICAL, INC.
ENSITE-FF-01
In Commercial Distribution

  • 05415067032195 ()
ENSITE-FF-01

  • Electromagnetic surgical navigation device tracking system
Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-01
In Commercial Distribution

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system
HF Cardiac Resynchronisation Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA500Q
In Commercial Distribution

  • 05415067032010 ()
CDHFA500Q

  • Cardiac resynchronization therapy implantable defibrillator
DR Implantable Cardioverter Defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
CDDRA500Q
In Commercial Distribution

  • 05415067032003 ()
CDDRA500Q

  • Dual-chamber implantable defibrillator
VR Implantable Cardioverter Defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CDVRA500Q
In Commercial Distribution

  • 05415067031990 ()
CDVRA500Q

  • Single-chamber implantable defibrillator
Link Module Programmer Communication Module
ST. JUDE MEDICAL, INC.
LSL02
In Commercial Distribution

  • 05415067031914 ()
LSL02

  • Intracardiac pacemaker programming interface unit
X EP System Catheter Connector Cable
ST. JUDE MEDICAL, INC.
A-ENS-MAGEXT-CBL
In Commercial Distribution

  • 05415067031822 ()
A-ENS-MAGEXT-CBL

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

  • 05415067031815 ()

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

  • Electrical-only medical device connection cable, reusable
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
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