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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™ - 05415067042477

X EP System Advanced Mapping Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AM-2.0
In Commercial Distribution

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software

EnSite™ - 05415067053138

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067051110

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050298

X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067048400

X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software

OnPoint Surgical Cart - 00850051682485

OnPoint Surgical Cart (with pre-installed software) - 2 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682485 ()
NK0210301

  • Orthopaedic stereotactic surgery system

OnPoint Surgical Cart - 00850051682386

OnPoint Surgical Cart (with pre-installed software) - 3 headsets
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682386 ()
NK0210301

  • Orthopaedic stereotactic surgery system

RALS - 00850049633161

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.2.0
In Commercial Distribution

  • 00850049633161 ()
8.2.0

  • Medical equipment clinical data interfacing software

RALS - 00850049633130

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.1
In Commercial Distribution

  • 00850049633130 ()
8.1.1

  • Medical equipment clinical data interfacing software

RALS - 00850049633123

RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.0
In Commercial Distribution

  • 00850049633123 ()
8.1.0

  • Medical equipment clinical data interfacing software
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