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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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BIS - 10884521129832

BISX Module,Software Version 1.15,For use with BIS Complete Monitors
Covidien LP
186-0195-AMS
In Commercial Distribution

  • 10884521129832 ()


  • Anaesthesia depth monitor

BIS - 10884521129825

BISX Module,Refurbished, Software Version 1.15
Covidien LP
186-0199-RFB
In Commercial Distribution

  • 10884521129825 ()


  • Neurophysiologic monitoring system

BIS - 10884521129788

BISX Module,Software Version 1.13,For use with Nihon Kohden Patient Monitors
Covidien LP
186-0195-NK
In Commercial Distribution

  • 10884521129788 ()


  • Anaesthesia depth monitor

BIS - 10884521129740

BISX Module,Software Version 1.13,For use with OEM Patient Monitors
Covidien LP
186-0195-SF
In Commercial Distribution

  • 10884521129740 ()


  • Anaesthesia depth monitor

BIS - 10884521129726

BISX Module,Software Version 1.13,For use with Drager Patient Monitors
Covidien LP
186-0195-DM
In Commercial Distribution

  • 10884521129726 ()


  • Anaesthesia depth monitor

BIS - 10884521129689

Monitoring System,Refurbished,For View Monitors
Covidien LP
186-1002-RFB
Not in Commercial Distribution

  • 10884521129689 ()


  • Anaesthesia depth monitor

BIS - 10884521129665

BISX Module,Software Version 1.13,For use with GE Patient Monitors
Covidien LP
186-0195-GE
Not in Commercial Distribution

  • 10884521129665 ()


  • Anaesthesia depth monitor

BIS - 10884521129658

BISX Module,Software Version 1.13,For use with Mindray Patient Monitors
Covidien LP
186-0195-MR
In Commercial Distribution

  • 10884521129658 ()


  • Anaesthesia depth monitor

BIS - 10884521129559

BISX4 Module,Software Version 1.15,For use with BIS Complete Monitors
Covidien LP
186-0224-AMS
In Commercial Distribution

  • 10884521129559 ()


  • Anaesthesia depth monitor

BIS - 10884521129528

Complete Monitoring System
Covidien LP
186-1047
In Commercial Distribution

  • 10884521129528 ()


  • Anaesthesia depth monitor

BIS - 10884521129511

Complete Monitoring System
Covidien LP
186-1046
In Commercial Distribution

  • 10884521129511 ()


  • Anaesthesia depth monitor

BIS - 10884521128859

Digital Signal Converter, DSC-XP,Refurbished,For Philips Medical Monitors
Covidien LP
186-0157-PH
Not in Commercial Distribution

  • 10884521128859 ()


  • Analytical scalp lead

BIS - 10884521128774

Digital Signal Converter, DSC-XP,Refurbished
Covidien LP
186-0157-RFB
Not in Commercial Distribution

  • 10884521128774 ()


  • Analytical scalp lead

miPlatform - 06970901070010

No Description
Hinacom Software and Technology, Ltd.
V2.0
In Commercial Distribution

  • 06970901070010 ()


  • Radiological PACS software

suiteHEART - 00850001088008

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution

  • 00850001088008 ()


  • MRI system application software

suiteHEART - 00850001088015

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software

Natus - 00382830061971

Software Upgrade from v22 to Natus Elite Software
NATUS NEUROLOGY INCORPORATED
033418
In Commercial Distribution

  • 00382830061971 ()


  • Electromyograph

Cardea SOLO - 00857553006139

Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution

  • 00857553006139 ()
D300

  • Electrocardiographic ambulatory recorder

NA - 07332747176353

O-Ring for Tools 2 sets of 5/pkg
Nobel Biocare AB
61760
Not in Commercial Distribution

  • 07332747193893 ()
  • 07332747176353 ()
61760

  • Dental implant suprastructure, temporary, preformed, single-use

Straumann Modular Cassette - 07630031740069

Straumann® Modular Cassette, C Module, Spare Tools
Institut Straumann AG
Storage Systems / Cassettes
In Commercial Distribution

  • 07630031740069 ()
041.773

  • Device sterilization/disinfection container, reusable
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