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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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Catphan® - 00812266030109

32cm OD 15cm thick uniformity material body annulus
Providus Holdings, Inc.
CTP653-15
In Commercial Distribution

  • 00812266030109 ()
CTP653-15

  • CT phantom, test object

Model 4 CT Calibration Phantom - B052PHCTM40

Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object

Puritan Bennett - 30884521252954

End Tidal CO2 Monitoring Option For 980 Series Ventilator
Covidien LP
10084332
In Commercial Distribution

  • 30884521252954 ()


  • Ventilator application software

LUX-Dx™ - 00802526625404

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-110
In Commercial Distribution

  • 00802526625404 ()
667256-110

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623110

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software

myLUX™ - 00802526621307

Patient Kit
BOSTON SCIENTIFIC CORPORATION
666385-100
In Commercial Distribution

  • 00802526621307 ()
666385-100

  • Implantable cardiac device management application software

LUX-Dx™ Clinic Assistant Mobile Device - 00802526621017

For use with Insertable Cardiac Monitor system
BOSTON SCIENTIFIC CORPORATION
667256-100
In Commercial Distribution

  • 00802526621017 ()
667256-100

  • Implantable cardiac device management application software

myLUX™ patient app - 00802526607608

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software

LUX-Dx™ Clinic Assistant Kit with mobile device - 00802526607370

LUX-Dx(TM) Clinic Assistant Kit with mobile device
BOSTON SCIENTIFIC CORPORATION
666256-100
In Commercial Distribution

  • 00802526607370 ()
666256-100

  • Implantable cardiac device management application software

myLUX™ Patient Kit with mobile device - 00802526607363

MyLUX(TM) Patient Kit with mobile device
BOSTON SCIENTIFIC CORPORATION
666259-100
In Commercial Distribution

  • 00802526607363 ()
666259-100

  • Implantable cardiac device management application software
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