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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 - 00801741187636

Lutonix 035 7X80MMX40CM
LUTONIX, INC.
LX3540780V
In Commercial Distribution

  • 00801741187636 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 40 Centimeter
LX3540780V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184727

Lutonix 018 6X300MMX130CM
LUTONIX, INC.
LX1813063005F
In Commercial Distribution

  • 00801741184727 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1813063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184710

Lutonix 018 5X300MMX130CM
LUTONIX, INC.
LX1813053005F
In Commercial Distribution

  • 00801741184710 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
LX1813053005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184703

Lutonix 018 4X300MMX130CM
LUTONIX, INC.
LX1813043005F
In Commercial Distribution

  • 00801741184703 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 4 Millimeter
LX1813043005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184697

Lutonix 018 6X300MMX100CM
LUTONIX, INC.
LX1810063005F
In Commercial Distribution

  • 00801741184697 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 6 Millimeter
LX1810063005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184680

Lutonix 018 5X300MMX100CM
LUTONIX, INC.
LX1810053005F
In Commercial Distribution

  • 00801741184680 ()

  • Balloon Length, 300 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 100 Centimeter
LX1810053005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741184673

Lutonix 018 4X300MMX100CM
LUTONIX, INC.
LX1810043005F
In Commercial Distribution

  • 00801741184673 ()

  • Balloon Length, 300 Millimeter
  • Catheter Length, 100 Centimeter
  • Balloon Diameter, 4 Millimeter
LX1810043005F

  • Peripheral angioplasty balloon catheter, drug-coated

Disposable Biopsy Valve - 06970900850934

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-O-EO
In Commercial Distribution

  • 06970900850934 ()


  • Endoscope working-channel valve, single-use

Andorate® - 06970661241545

No Description
Smartdata Suzhou Co., Ltd.
GAR028S
In Commercial Distribution

  • 16970661241542 ()
  • 06970661241545 ()
  • 26970661241549 ()


  • Endoscope working-channel valve, single-use

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135798

Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x100
LUTONIX, INC.
LX351001240V
In Commercial Distribution

  • 00801741135798 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
LX351001240V

  • Peripheral angioplasty balloon catheter, drug-coated
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