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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 DCB, 7mm x 120mm x 130cm, 5F
LUTONIX, INC.
LX3513071205F
In Commercial Distribution

  • 00801741163456 ()

  • Balloon Length, 120 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 7 Millimeter
LX3513071205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 7mm x 80mm x 130cm, 5F
LUTONIX, INC.
LX351307805F
In Commercial Distribution

  • 00801741163432 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 7 Millimeter
LX351307805F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 5mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513052205F
In Commercial Distribution

  • 00801741163418 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
LX3513052205F

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix 035 DCB, 4mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513042205F
In Commercial Distribution

  • 00801741163401 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX3513042205F

  • Peripheral angioplasty balloon catheter, drug-coated
No Description
Acuitive Technologies, Inc.
40-103-0014
In Commercial Distribution

  • 00810027271013 ()
40-103-0014

  • Surgical flat-nosed pliers
No Description
Acuitive Technologies, Inc.
40-103-0013
In Commercial Distribution

  • 00810027271006 ()
40-103-0013

  • Surgical flat-nosed pliers
No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-O-EO
In Commercial Distribution

  • 06970900850934 ()


  • Endoscope working-channel valve, single-use
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, 130cm, 7x150mm
LUTONIX, INC.
LX351307150
Not in Commercial Distribution

  • 00801741088773 ()

  • Balloon Diameter, 7 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Length, 150 Millimeter
LX351307150

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm
LUTONIX, INC.
LX351306150
Not in Commercial Distribution

  • 00801741088766 ()

  • Balloon Diameter
  • Balloon Length
  • Catheter Length
LX351306150

  • Peripheral angioplasty balloon catheter, drug-coated
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