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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
Edwards Lifesciences LLC
916ES
In Commercial Distribution

  • 00690103193992 ()

  • 16F
916ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
No Description
Edwards Lifesciences LLC
914ES
In Commercial Distribution

  • 00690103193985 ()

  • 14F
914ESA

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images.
FUJIFILM CORPORATION
DR 3500 TOMO KIT V2.0 USA E
In Commercial Distribution

  • 04547410351316 ()


  • Stationary mammographic x-ray system, digital
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-230-38U
In Commercial Distribution

  • 00843576154209 ()

  • Catheter Gauge: 21 French
  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 38 Millimeter
  • Length: 244 Millimeter
28-M4-24-230-38U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-210-38U
In Commercial Distribution

  • 00843576154193 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 38 Millimeter
  • Length: 222 Millimeter
  • Catheter Gauge: 21 French
28-M4-24-210-38U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-190-38U
In Commercial Distribution

  • 00843576154186 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 38 Millimeter
  • Length: 199 Millimeter
  • Catheter Gauge: 21 French
28-M4-24-190-38U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-170-38U
In Commercial Distribution

  • 00843576154179 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 38 Millimeter
  • Length: 190 Millimeter
  • Catheter Gauge: 21 French
28-M4-24-170-38U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-150-38U
In Commercial Distribution

  • 00843576154162 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 38 Millimeter
  • Length: 169 Millimeter
  • Catheter Gauge: 21 French
28-M4-24-150-38U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-250-36U
In Commercial Distribution

  • 00843576154155 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 36 Millimeter
  • Length: 264 Millimeter
  • Catheter Gauge: 20 French
28-M4-24-250-36U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-230-36U
In Commercial Distribution

  • 00843576154148 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 36 Millimeter
  • Length: 244 Millimeter
  • Catheter Gauge: 20 French
28-M4-24-230-36U

  • Descending thoracic aorta endovascular stent-graft
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