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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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EPIQ 5 Ultrasound Circular Edition - 00884838113886

Software Version 9.X
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838113886 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Ultrasound Circular Edition - 00884838113862

Software version 9.X
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113862 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Ultrasound Circular Edition - 00884838113855

Software version 7.x
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113855 ()


  • General-purpose ultrasound imaging system

Affiniti 50 Ultrasound Circular Edition - 00884838113831

Software Version 7.X
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838113831 ()


  • General-purpose ultrasound imaging system

EPIQ 7 Ultrasound Circular Edition - 00884838113824

Software Version 9.X
Philips Ultrasound LLC
795117
In Commercial Distribution

  • 00884838113824 ()


  • General-purpose ultrasound imaging system

Sparq Ultrasound Circular Edition - 00884838113800

Software version 3.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113800 ()


  • General-purpose ultrasound imaging system

Sparq Ultrasound Circular Edition - 00884838113794

Software version 2.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113794 ()


  • General-purpose ultrasound imaging system

CX50 Ultrasound Circular Edition - 00884838113787

Software version 5.X
Philips Ultrasound LLC
795114
In Commercial Distribution

  • 00884838113787 ()


  • General-purpose ultrasound imaging system

EPIQ Elite W Diagnostic Ultrasound System - 00884838111004

Software version 6.X
Philips Ultrasound LLC
795258
In Commercial Distribution

  • 00884838111004 ()


  • General-purpose ultrasound imaging system

Invivo - 00884838081550

UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software

SPOTCHECK - 00725609000434

NeoPac Software with Manual
ASTORIA-PACIFIC, INC.
307-C001-00
In Commercial Distribution

  • 00725609000434 ()
307-C001-00

  • Laboratory instrument/analyser application software IVD

Welch Allyn, Inc. - 00732094356861

DVD SOFTWARE VISION V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356861 ()
109203

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094326802

E-Scribe Oracle Database Software
WELCH ALLYN, INC.
901134
Not in Commercial Distribution

  • 00732094326802 ()
108086

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094320800

XSCRIBE V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094320794

Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094319057

Software Rest Interp v7.5
WELCH ALLYN, INC.
901155
In Commercial Distribution

  • 00732094319057 ()
107440

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094281385

SOFTWARE Q-STRESS & RSCRIBE V6.2.2
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094281385 ()
11107-005-50

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094272468

SOFTWARE H-SCRIBE VER 4.34
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094272468 ()
11013-018-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272437

SOFTWARE ASSY R-SCRIBE V1.10.10
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094272437 ()
11017-002-50

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094272390

SOFTWARE SURVEYOR IMPORT V4.10
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094272390 ()
11054-009-50

  • Centralized patient monitor
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