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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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3Dimensions - 15420045507296

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital

BIS Module - 00884838051515

IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Philips Medizin Systeme Böblingen GmbH
IntelliVue BIS Module
In Commercial Distribution

  • 00884838051515 ()
866421

  • Patient monitoring system module, interfacing

Rapid - B761R51020

Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software

UltraviewSL - 10841522108754

OPTION, BISX BASE MODULE, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
91482
In Commercial Distribution

  • 10841522108754 ()
N/A

  • Patient monitoring system module, electroencephalographic

UltraviewSL - 10841522100253

MODULE BISX, 91482
SPACELABS HEALTHCARE (WASHINGTON), INC
Module: BISx
In Commercial Distribution

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic

BIS - 10884521808317

BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead

BIS - 10884521808300

BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor

BIS - 10884521808270

BIS (TM) Advance Monitor
Covidien LP
PMB4000
In Commercial Distribution

  • 10884521808270 ()


  • Anaesthesia depth monitor

TREON® plus and TRIA® plus - 00721902849787

SOFTWARE 9730877 ORTHO LICENSE (PLUS)
MEDTRONIC NAVIGATION, INC.
9730877
Not in Commercial Distribution

  • 00721902849787 ()


  • Multi-purpose stereotactic surgery system

LUCAS Report Generator - 00883873851913

SOFTWARE EXECUTABLE, LUCAS Report Generator
PHYSIO-CONTROL, INC.
60600
In Commercial Distribution

  • 00883873851913 ()
60600-000145

  • Medical equipment clinical data interfacing software
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