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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A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500921 ()
70564-001

  • Laboratory instrument/analyser application software IVD
A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500914 ()
ASY-06042

  • Laboratory instrument/analyser application software IVD
A microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045500891 ()
71062-001

  • Basic light microscope
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
Hologic, Inc.
ThinPrep 3000 Processor
Not in Commercial Distribution

  • 15420045500846 ()
70150-001

  • Microscope slide maker IVD
Accessory kit with components for installation of the ThinPrep® 5000 processor.
Hologic, Inc.
TP-5000 Accessory Kit
In Commercial Distribution

  • 15420045513945 ()
71914-001

  • Microscope slide maker IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD
No Description
Biomet Orthopedics, LLC
16-116080
In Commercial Distribution

  • 00880304593251 ()

  • 80MM SHELL SIZE 28 LINER SIZE
16-116080

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
16-116078
In Commercial Distribution

  • 00880304593244 ()

  • 78MM SHELL SIZE 28 LINER SIZE
16-116078

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
16-116076
In Commercial Distribution

  • 00880304593237 ()

  • 76MM SHELL SIZE 28 LINER SIZE
16-116076

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
16-116074
In Commercial Distribution

  • 00880304593220 ()

  • 74MM SHELL SIZE 28 LINER SIZE
16-116074

  • Acetabular shell
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