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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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Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD
No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system
No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system
No Description
Vektor Medical, Inc.
VMCU2
In Commercial Distribution

  • 00860007954122 ()


  • Cardiac mapping system workstation
No Description
Vektor Medical, Inc.
VMDISP2
In Commercial Distribution

  • 00860007954115 ()


  • Cardiac mapping system workstation
X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software
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
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system
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