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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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Unitron - 07613389303285

TrueFit Fitting Software v4.x
Unitron Hearing Division
058-5235
In Commercial Distribution

  • 07613389303285 ()
058-5235

  • Audiometric/hearing device software

EXACTECHGPS - 10885862518767

SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system

n.a. - 04048551357286

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-45
In Commercial Distribution

  • 04048551357286 ()


  • Operating room audiovisual data/device management system application software

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231124

Site~Rite 9 Ultrasound Software
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution

  • 00801741231124 ()
SR9v1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219221

SiteRite 9 Sherlock Software v3.3.1
Bard Access Systems, Inc.
Sherlockv3.3.1
In Commercial Distribution

  • 00801741219221 ()
Sherlockv3.3.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Synergy®Cranial - 00763000253158

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00763000253158 ()


  • Multi-purpose stereotactic surgery system

PillCam - 07290110360795

PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software

CareLink™ - 00763000424138

PRODUCT SOFTWARE MMT-7350 PROWEB 3.13A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000424138 ()


  • Patient health record information system application software

uWS - 06971576834037

PET/CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MI
In Commercial Distribution

  • 06971576834037 ()


  • Radiology DICOM image processing application software

Kaluza C - 15099590705169

Kaluza C Flow Cytometry Software
Beckman Coulter, Inc.
Flow Cytometry Software
In Commercial Distribution

  • 15099590705169 ()
C21166

  • Laboratory instrument/analyser application software IVD
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