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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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TrakStar Patient Data Management System Software - 00850005944133

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Cloud)
In Commercial Distribution

  • 00850005944133 ()
83-00060-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944126

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Cloud)
In Commercial Distribution

  • 00850005944126 ()
83-00060-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944102

Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Local)
In Commercial Distribution

  • 00850005944102 ()
83-00056-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944096

Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Local)
In Commercial Distribution

  • 00850005944096 ()
83-00056-000

  • Magnetic neural stimulation system

REMI - 00860005388172

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
1.x.x.x
Not in Commercial Distribution

  • 00860005388172 ()


  • Electroencephalographic monitoring system

HolterCare Editing Kit - 00856298006268

License dongle for second workstation using the HolterCare software.
SCOTTCARE CORPORATION, THE
HolterCare Editing Kit
In Commercial Distribution

  • 00856298006268 ()
100080

  • Electrocardiographic long-term ambulatory recording analyser application software

ABACUS - 05413765577369

ABACUS Order Entry & Calculation Software versions 3.3.x ME
BAXTER HEALTHCARE CORPORATION
83003393
In Commercial Distribution

  • 05413765577369 ()
83003393

  • Intravenous solution compounder

ABACUS - 05413765577352

ABACUS ORDER ENTRY & CALCULATION SOFTWARE VERSIONS 3.3.X SE
BAXTER HEALTHCARE CORPORATION
83003392
In Commercial Distribution

  • 05413765577352 ()
83003392

  • Intravenous solution compounder

ABACUS - 05413765577345

ABACUS Order Entry & Calculation Software versions 3.3.x CE
BAXTER HEALTHCARE CORPORATION
83003391
In Commercial Distribution

  • 05413765577345 ()
83003391

  • Intravenous solution compounder

ABACUS - 05413765577321

ABACUS Order Entry & Calculation Software versions 3.3.x DE
BAXTER HEALTHCARE CORPORATION
83003390
In Commercial Distribution

  • 05413765577321 ()
83003390

  • Intravenous solution compounder
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