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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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No Description
Opsens Inc
AUX interface cable - Siemens Axiom
In Commercial Distribution

  • 07540184011124 ()
F201112

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - GE TRAM 450SL
In Commercial Distribution

  • 07540184011117 ()
F201111

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - GE PDM
In Commercial Distribution

  • 07540184011100 ()
F201110

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Jack 3.5mm
In Commercial Distribution

  • 07540184011094 ()
F201109

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Mennen CFE
In Commercial Distribution

  • 07540184011087 ()
F201108

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Siemens Sensis
In Commercial Distribution

  • 07540184011070 ()
F201107

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Mennen Model 267
In Commercial Distribution

  • 07540184011063 ()
F201106

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - D15 GE TRAM
In Commercial Distribution

  • 07540184011056 ()
F201105

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - GE TRAM
In Commercial Distribution

  • 07540184011049 ()
F201104

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Jack 1/4"
In Commercial Distribution

  • 07540184011032 ()
F201103

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - Siemens Axiom
In Commercial Distribution

  • 07540184011025 ()
F201102

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AUX interface cable - BNC male (Philips)
In Commercial Distribution

  • 07540184011018 ()
F201101

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
AC Power cord C13 to P5 15P HG NA
In Commercial Distribution

  • 07540184010042 ()
F201004

  • Cardiac catheterization laboratory computer
No Description
Opsens Inc
Power Supply SL Power 12V Opsens
In Commercial Distribution

  • 07540184010035 ()
F201003

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

  • 00847817015786 ()
2702601

  • Glycated haemoglobin (HbA1C) analyser IVD
WATS Biopsy Instrument for Computer Assisted 3D Analysis
ENDO-THERAPEUTICS, INC.
WGB-200-006
In Commercial Distribution

  • 00816207021713 ()

  • Sheath Diameter 3.0 mm
  • Length: 200 Centimeter
  • Brush Diameter 1.7 mm
  • Min Channel 4.2 mm
  • Guide Wire Size 0.035 in
WGB-200-006

  • Flexible endoscopic cytology brush, single-use
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
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
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504035 ()
CMP-01284

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500990 ()
CMP-00815

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500983 ()
71278-001

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500976 ()
71964-001

  • Laboratory instrument/analyser application software IVD
Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500945 ()
71074-001

  • Laboratory instrument/analyser application software 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
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