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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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LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135279

Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x40
LUTONIX, INC.
LX35401060V
Not in Commercial Distribution

  • 00801741135279 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
LX35401060V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135262

Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x40
LUTONIX, INC.
LX35401040V
Not in Commercial Distribution

  • 00801741135262 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 10 millimeter
LX35401040V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135255

Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x40
LUTONIX, INC.
LX35401020V
In Commercial Distribution

  • 00801741135255 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 10 millimeter
  • Catheter Length, 40 centimeter
LX35401020V

  • Peripheral angioplasty balloon catheter, drug-coated

CONTOUR® NEXT - 00301937283352

Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use

GORE EXCLUDER AAA Endoprosthesis - 00733132618248

Contralateral Leg
W. L. Gore & Associates, Inc.
PXC231000
Not in Commercial Distribution

  • 00733132618248 ()

  • Outer Diameter: 23 Millimeter
  • Outer Diameter: 16 Millimeter
  • Length: 10 Centimeter
PXC231000

  • Abdominal aorta endovascular stent-graft

GORE EXCLUDER AAA Endoprosthesis - 00733132618224

Contralateral Leg
W. L. Gore & Associates, Inc.
PXC271000
Not in Commercial Distribution

  • 00733132618224 ()

  • Length: 10 Centimeter
  • Outer Diameter: 16 Millimeter
  • Outer Diameter: 27 Millimeter
PXC271000

  • Abdominal aorta endovascular stent-graft

GORE TAG Conformable Thoracic Endoprosthesis - 00733132618040

TAG THORACIC ENDO CONFORM 31-26mmX10cm 22Fr Tapered
W. L. Gore & Associates, Inc.
TGU312610
In Commercial Distribution

  • 00733132618040 ()

  • Outer Diameter: 31 Millimeter
  • Outer Diameter: 26 Millimeter
  • Length: 10 Centimeter
TGU312610

  • Descending thoracic aorta endovascular stent-graft

GORE TAG Conformable Thoracic Endoprosthesis - 00733132617791

TAG THORACIC ENDO CONFORM 26-21mmX10cm 20Fr Tapered
W. L. Gore & Associates, Inc.
TGU262110
In Commercial Distribution

  • 00733132617791 ()

  • Outer Diameter: 21 Millimeter
  • Outer Diameter: 26 Millimeter
  • Length: 10 Centimeter
TGU262110

  • Descending thoracic aorta endovascular stent-graft

GORE VIABAHN Endoprosthesis with Heparin - 00733132615179

VIABAHN SX ENDO HEPARIN 35 11mmX10cm 11Fr 120cmCath
W. L. Gore & Associates, Inc.
VBH111002
In Commercial Distribution

  • H373VBH11100239 ()
  • 00733132615179 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 11 Millimeter
  • Catheter Gauge: 11 French
VBH111002

  • Peripheral artery endovascular stent-graft, drug-coated

GORE TAG Thoracic Branch Endoprosthesis - 00733132654024

TAG TBE THORACIC AORTIC BRANCH 26mmX10cmX8mm
W. L. Gore & Associates, Inc.
TAC082610A
In Commercial Distribution

  • 00733132654024 ()

  • Catheter Gauge: 20 French
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 26 Millimeter
TAC082610A

  • Aortic arch endovascular stent-graft
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