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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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Ranger™ - 00191506046620

MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939733406020
In Commercial Distribution

  • 00191506046620 ()

  • Balloon Length: 60 Millimeter
  • Length: 200 Centimeter
  • Balloon Diameter: 4 Millimeter
H74939733406020

  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 00191506046613

MONORAIL™ Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939733404020
In Commercial Distribution

  • 00191506046613 ()

  • Balloon Diameter: 4 Millimeter
  • Length: 200 Centimeter
  • Balloon Length: 40 Millimeter
H74939733404020

  • Peripheral angioplasty balloon catheter, drug-coated

TraumaOne SYSTEM - 00841036284619

No Description
BIOMET MICROFIXATION, INC
46-0009
In Commercial Distribution

  • 00841036284619 ()
46-0009

  • Surgical flat-nosed pliers

LUTONIX® Drug Coated Balloon - 00801741178740

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 7x220mm
LUTONIX, INC.
LX351307220
Not in Commercial Distribution

  • 00801741178740 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
LX351307220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741178733

LUTONIX® 035 Drug Coated Balloon PTA Catheter, 130cm, 6x220mm
LUTONIX, INC.
LX351306220
Not in Commercial Distribution

  • 00801741178733 ()

  • Balloon Length, 220 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX351306220

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177767

Lutonix 018 7X150MMX130CM
LUTONIX, INC.
LX1813071505F
In Commercial Distribution

  • 00801741177767 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX1813071505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177743

Lutonix 018 7X100MMX130CM
LUTONIX, INC.
LX1813071005F
In Commercial Distribution

  • 00801741177743 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 7 Millimeter
LX1813071005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177729

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 7X60MMX130CM
LUTONIX, INC.
LX181307605F
In Commercial Distribution

  • 00801741177729 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
LX181307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177705

LUTONIX® 018 Drug Coated Balloon PTA Catheter, 6X220MMX130CM
LUTONIX, INC.
LX1813062205F
In Commercial Distribution

  • 00801741177705 ()

  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
  • Balloon Length, 220 Millimeter
LX1813062205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177682

LUTONIX® 018 Drug Coated Balloon PTA Catheter 6X120MMX130CM
LUTONIX, INC.
LX1813061205F
In Commercial Distribution

  • 00801741177682 ()

  • Balloon Length, 120 Millimeter
  • Balloon Diameter, 6 Millimeter
  • Catheter Length, 130 Centimeter
LX1813061205F

  • Peripheral angioplasty balloon catheter, drug-coated
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