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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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PULSE - 00195377065520

PULSE Software, v4.0.0-bl.eu
Nuvasive, Inc.
1802493
In Commercial Distribution

  • 00195377065520 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065513

PULSE Software, v4.0.0-bl.us
Nuvasive, Inc.
1802491
In Commercial Distribution

  • 00195377065513 ()


  • Orthopaedic stereotactic surgery system

Clarity® - 07540180000221

Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system

ILLUMISITE - 10884521779990

Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system

ILLUMISITE - 10884521779983

Procedure Software V1.0
Covidien LP
Procedure Application V1.0
In Commercial Distribution

  • 10884521779983 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747432

v7.1 Planning Software
Covidien LP
PMB00569-01
In Commercial Distribution

  • 10884521747432 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747425

v7.2 Procedure Software
Covidien LP
PMB00667-01
In Commercial Distribution

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system

True Lok System - 18054242511847

TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software

syngo Application Software Media - 04056869025902

syngo Application Software VD1;syngo Application Software Media;Registered Medical Devices:syngo Application Software – GTIN 04056869012902
Siemens Healthcare GmbH
10849116
In Commercial Distribution

  • 04056869025902 ()


  • Basic diagnostic x-ray system application software

Norav 1200 Series PC-ECG - 07290110252779

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2
In Commercial Distribution

  • 07290110252779 ()
HASP-SW-K-S2-01

  • Cardiopulmonary stress exercise monitoring system computer
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