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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 ®Drug Coated Balloon - 00801741088032

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
LX3575560
Not in Commercial Distribution

  • 00801741088032 ()

  • Balloon Diameter,5 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088025

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm
LUTONIX, INC.
LX3575460
Not in Commercial Distribution

  • 00801741088025 ()

  • Balloon Diameter,4 Millimeter
  • Balloon Length,60 Millimeter
  • Catheter Length,75 Centimeter
LX3575460

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741088018

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm
LUTONIX, INC.
LX3575740
Not in Commercial Distribution

  • 00801741088018 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
LX3575740

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741088001

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm
LUTONIX, INC.
LX3575640
Not in Commercial Distribution

  • 00801741088001 ()

  • Balloon Length,40 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Diameter,6 Millimeter
LX3575640

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741087998

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm
LUTONIX, INC.
LX3575540
Not in Commercial Distribution

  • 00801741087998 ()

  • Balloon Diameter,5 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575540

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741087981

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm
LUTONIX, INC.
LX3575440
Not in Commercial Distribution

  • 00801741087981 ()

  • Balloon Diameter,4 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,40 Millimeter
LX3575440

  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ AV - 00763000232740

DCB IAV04008004P 04.00 L080 UL0400 US
MEDTRONIC, INC.
IAV04008004P
In Commercial Distribution

  • 00763000232740 ()

  • Length: 80.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ AV - 00763000232733

DCB IAV04006004P 04.00 L060 UL0400 US
MEDTRONIC, INC.
IAV04006004P
In Commercial Distribution

  • 00763000232733 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ AV - 00763000232726

DCB IAV04004004P 04.00 L040 UL0400 US
MEDTRONIC, INC.
IAV04004004P
In Commercial Distribution

  • 00763000232726 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 40.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ AV - 00763000232719

DCB IAV12004008P 12.00 L040 UL0800 US
MEDTRONIC, INC.
IAV12004008P
In Commercial Distribution

  • 00763000232719 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 12.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
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