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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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Single Use Brush Biopsy Instrument - 00816207021706

WATS Biopsy Instrument for Computer Assisted 3D Analysis
ENDO-THERAPEUTICS, INC.
TNL-80
In Commercial Distribution

  • 00816207021706 ()

  • Length: 80 Centimeter
  • Brush Diameter 1.7 mm
  • Min Channel 2.0 mm
TNL-80

  • Flexible endoscopic cytology brush, single-use

Single Use Brush Biopsy Instrument - 00816207021690

WATS Biopsy Instrument for Computer Assisted 3D Analysis
ENDO-THERAPEUTICS, INC.
TNE-110
In Commercial Distribution

  • 00816207021690 ()

  • Length: 110 Centimeter
  • Brush Diameter 1.7 mm
  • Min Channel 2.0 mm
TNE-110

  • Flexible endoscopic cytology brush, single-use

Single Use Brush Biopsy Instrument - 00816207021041

WATS Biopsy Instrument for Computer Assisted 3D Analysis
ENDO-THERAPEUTICS, INC.
EGD-230-006
In Commercial Distribution

  • 00816207021041 ()

  • Length: 230 Centimeter
  • Brush Diameter 1.8 mm
  • Min Channel 2.8 mm
EGD-230-006

  • Flexible endoscopic cytology brush, single-use

Single Use Brush Biopsy Instrument - 00816207021027

WATS Biopsy Instrument for Computer Assisted 3D Analysis
ENDO-THERAPEUTICS, INC.
EGD-160-006
In Commercial Distribution

  • 00816207021027 ()

  • Sheath Diameter 2.6 mm
  • Length: 160 Centimeter
  • Brush Diameter 1.8 mm
  • Min Channel 2.8 mm
EGD-160-006

  • Flexible endoscopic cytology brush, single-use

DIGITAL DIAGNOSTICS SYSTEM - 15420045517585

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045517097

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512511

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

DIGITAL DIAGNOSTICS SYSTEM - 15420045513914

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045513914 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045513884

Computer to operate the Genius™ Digital Imager.
Hologic, Inc.
COMPUTER, DIGITAL IMAGER
In Commercial Distribution

  • 15420045513884 ()
CMP-01687

  • Microscope slide digital imaging scanner IVD

Thinprep Imaging System - 15420045513716

Computer to operate the ThinPrep® Integrated Imager.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045513716 ()
CMP-01764

  • Laboratory instrument/analyser application software IVD
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