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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 Class Implantable

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EnSite™ - 05415067041722

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system

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™ - 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™ - 05415067034755

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-02
In Commercial Distribution

  • 05415067034755 ()
ENSITE-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067034748

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067032188

Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032171

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

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032164

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system

EnSite™ - 05415067032157

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system

MediGuide™ - 05415067023711

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

  • 05415067023711 ()
MG1000

  • Cardiac mapping system
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