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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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XACT ACE Xtend - 07290017702384

XACT ACE Xtend
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702384 ()
XR-ACE-XTEND

  • Computer/medical device keyboard

Horizon XVu - 07290102932788

Computerized Hemodynamic monitoring System
MENNEN MEDICAL LTD.
Lite_115V
In Commercial Distribution

  • 07290102932788 ()
960-800-315

  • Cardiac catheterization laboratory computer

Horizon XVu - 07290102932771

Computerized Hemodynamic monitoring System
MENNEN MEDICAL LTD.
115V
In Commercial Distribution

  • 07290102932771 ()
960-800-310

  • Cardiac catheterization laboratory computer

XACT ACE Xtend Remote - 07290017702377

XACT ACE Xtend Remote
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702377 ()
PR06ASA057003

  • Computer/medical device keyboard

VARIANT II TURBO - 00847817015786

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

  • 00847817015786 ()
2702601

  • Glycated haemoglobin (HbA1C) analyser IVD

Single Use Brush Biopsy Instrument - 00816207021713

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

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
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