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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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EnSite™ - 05415067037763

Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1
In Commercial Distribution

  • 05415067037763 ()
ENSITE-SW-1.1

  • Cardiac mapping system application software

EnSite™ - 05415067037756

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system

EnSite™ - 05415067037749

X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software

EnSite™ - 05415067037732

X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software

EnSite™ - 05415067037725

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-1.1
In Commercial Distribution

  • 05415067037725 ()
ENSITE-DWS-1.1

  • Cardiac mapping system

EnSite™ - 05415067037718

X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution

  • 05415067037718 ()
ENSITE-LV-01

  • Cardiac mapping system application software

EnSite™ - 05415067037701

X EP System Omnipolar Technology Software License
ST. JUDE MEDICAL, INC.
ENSITE-OT-01
In Commercial Distribution

  • 05415067037701 ()
ENSITE-OT-01

  • Cardiac mapping system application software

EnSite™ - 05415067037695

X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software

N/A - 05415067037572

Monitor Cable
ST. JUDE MEDICAL, INC.
C12849
In Commercial Distribution

  • 05415067037572 ()
C12849

  • Electrical-only medical device connection cable, reusable

WorkMate Claris™ - 05415067035615

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800012
In Commercial Distribution

  • 05415067035615 ()
H800012

  • Cardiac catheterization monitoring system
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