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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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Endotracheal Tube, Preformed, Oral, Uncuffed, Sterile, Size 3.5 mm Internal Diameter
ENDURE INDUSTRIES
ETPOU3561017
In Commercial Distribution

  • B531ETPOU3562 ()
  • B531ETPOU3561 ()
  • B531ETPOU3560 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
ETPOU356

  • Basic endotracheal tube, single-use
Preformed Endotracheal Tube, Oral, Cuffed, Size = 8.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC8061017
In Commercial Distribution

  • B531ETPOC8062 ()
  • B531ETPOC8061 ()
  • B531ETPOC8060 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
ETPOC806

  • Basic endotracheal tube, single-use
Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.5 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC6561017
In Commercial Distribution

  • B531ETPOC6562 ()
  • B531ETPOC6561 ()
  • B531ETPOC6560 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
ETPOC656

  • Basic endotracheal tube, single-use
Endotracheal Tube, Standard Type, Uncuffed, Size = 4.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU4051217
In Commercial Distribution

  • B531ETNU4052 ()
  • B531ETNU4051 ()
  • B531ETNU4050 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETNU405

  • Basic endotracheal tube, single-use
Endotracheal Tube, Standard Type, Uncuffed, Size = 3.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNU3051217
In Commercial Distribution

  • B531ETNU3052 ()
  • B531ETNU3051 ()
  • B531ETNU3050 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
ETNU305

  • Basic endotracheal tube, single-use
Endotracheal Tube, Standard Type, Cuffed, Size = 9.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC9051217
In Commercial Distribution

  • B531ETNC9052 ()
  • B531ETNC9051 ()
  • B531ETNC9050 ()

  • Lumen/Inner Diameter: 9.0 Millimeter
ETNC905

  • Basic endotracheal tube, single-use
Endotracheal Tube, Standard Type, Cuffed, Size = 8.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC8051217
In Commercial Distribution

  • B531ETNC8052 ()
  • B531ETNC8051 ()
  • B531ETNC8050 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
ETNC805

  • Basic endotracheal tube, single-use
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
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