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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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N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

Centralized Configuration Manager Software - 10711234540121

Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory

Welch Allyn, Inc. - 00817655023267

Software Eli Edit Standard
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023267 ()
107420

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00817655023250

Software Eli Edit Pro
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023250 ()
107422

  • Electrocardiograph, professional, multichannel

Vision - 00817655022642

Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11100-005-50
In Commercial Distribution

  • 00817655022642 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655022635

Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00817655020686

SOFTWARE E-SCRIBE WORKSTATION V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020686 ()
11012-016-51

  • Patient health record information system application software

Welch Allyn, Inc. - 00817655020679

SOFTWARE E-SCRIBE SERVER V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020679 ()
11012-016-50

  • Patient health record information system application software

X-Guide - 00817421023361

X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022838

X-Guide 3.6.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022838 ()


  • Surgical planning/navigation-enhancement system
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