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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™ - 05415067000910

Display Workstation
ST. JUDE MEDICAL, INC.
EE3000
In Commercial Distribution

  • 05415067000910 ()
EE3000

  • Cardiac mapping system

WorkMate™ - 05415067000897

CI Module 2
ST. JUDE MEDICAL, INC.
H700089
In Commercial Distribution

  • 05415067000897 ()
H700089

  • Cardiac catheterization monitoring system

WorkMate™ - 05415067000880

CI Module 1
ST. JUDE MEDICAL, INC.
H700088
In Commercial Distribution

  • 05415067000880 ()
H700088

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067000866

Software Upgrade Kit v.4.3.2
ST. JUDE MEDICAL, INC.
H700086
In Commercial Distribution

  • 05415067000866 ()
H700086

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067000712

PRS Patch
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 15415067000719 ()
  • 05415067000712 ()
H700071

  • Cardiac mapping system

EnSite™ - 05415067000026

GenConnect Module Generator Connector
ST. JUDE MEDICAL, INC.
H00002
In Commercial Distribution

  • 05415067000026 ()
H00002

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734219228

Cable
ST. JUDE MEDICAL, INC.
H21922
In Commercial Distribution

  • 05414734219228 ()
H21922

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734219211

Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software

EP-WorkMate™ - 05414734219105

No Description
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution

  • 05414734219105 ()
H21910

  • Cardiac catheterization monitoring system

EnSite Precision™ - 05415067026316

Bedrail Mount Kit
ST. JUDE MEDICAL, INC.
H702474
In Commercial Distribution

  • 05415067026316 ()
H702474

  • Medical device storage mount
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