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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™ - 05415067040770

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software

NA - 00643169648975

SOFTWARE CD S0278-00 GRAV FIT
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169648975 ()


  • Audiometric/hearing device software

N/A - 00643169272583

SOFTWARE KIT 9735235 MICROSCOPE ROBOTICS
MEDTRONIC NAVIGATION, INC.
9735235
In Commercial Distribution

  • 00643169272583 ()


  • Neurological stereotactic surgery system

Littmann® Telesteth™ - 00707387766597

TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software

Nexstim NBS software GER - 06430063200064

Nexstim NBS German Main Software
NEXSTIM, INC.
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph

Smartdop XT6 - 00894912002968

Bidirectional Doppler with Smart-XT-Link6 software
KOVEN TECHNOLOGY, INC.
Smartdop XT6
In Commercial Distribution

  • 00894912002968 ()
Smartdop XT6

  • Noninvasive vascular ultrasound system, line-powered

VITEK®2 - 03573026609399

CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

NUCLISENS® easyMAG® SOFTWARE V2. 1 - 03573026448301

EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD

CRW® - 10381780252634

ImageFusion 3 Software Install Kit
INTEGRA LIFESCIENCES CORPORATION
IF3000
Not in Commercial Distribution

  • M433IF30001 ()
  • 10381780252634 ()


  • Stereotactic radiosurgical invasive head frame

Integra® NeuroSight® - 10381780252627

NeuroSight Arc Software on Laptop
INTEGRA LIFESCIENCES CORPORATION
ST1000
Not in Commercial Distribution

  • M433ST10001 ()
  • 10381780252627 ()
ST1000

  • Neurological stereotactic surgery system
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