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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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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
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
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
VARIANT II TURBO Hemoglobin Testing System WITHOUT Computer
BIO-RAD LABORATORIES, INC.
270-2601
In Commercial Distribution

  • 00847817015786 ()
2702601

  • Glycated haemoglobin (HbA1C) analyser IVD
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
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
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
Computer to operate the Genius™ Digital Imager.
Hologic, Inc.
COMPUTER, DIGITAL IMAGER
In Commercial Distribution

  • 15420045513884 ()
CMP-01687

  • Microscope slide digital imaging scanner IVD
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
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
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