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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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Epidural Disposable Kit - 00618874601102

Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6011
In Commercial Distribution

  • 00618874601102 ()


  • Electronic epidural space locator pressure-sensing set

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

BRAEBON MediByte - B14088900

Cable to connect MediByte to a computer for configuration and data upload.
Braebon Medical Corporation
8890
In Commercial Distribution

  • B14088900 ()
8890

  • Electrical-only medical device connection cable, reusable

Thinprep Imaging System - 15420045508163

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045508163 ()
ASY-11145

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501034

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • Laboratory instrument/analyser application software IVD

TOPOGRAPHIC MODELING SYSTEM - 04582273612129

with 31 cone
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612129 ()


  • Corneal topography system

TOPOGRAPHIC MODELING SYSTEM - 04582273612099

100V
TOMEY CORPORATION.
TMS-4N
In Commercial Distribution

  • 04582273612099 ()


  • Corneal topography system
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