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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 .035" 75cm 7x60mm
LUTONIX, INC.
LX3575760
Not in Commercial Distribution

  • 00801741088056 ()

  • Balloon Diameter, 7 Millimeter
  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
LX3575760

  • Peripheral angioplasty balloon catheter, drug-coated
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm
LUTONIX, INC.
LX3575660
Not in Commercial Distribution

  • 00801741088049 ()

  • Balloon Diameter,6 Millimeter
  • Catheter Length,75 Centimeter
  • Balloon Length,60 Millimeter
LX3575660

  • Peripheral angioplasty balloon catheter, drug-coated
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® 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® 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® 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® 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® 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
Non-sterile
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-B-BV02
In Commercial Distribution

  • 16970401817150 ()
  • 06970401817146 ()
  • 26970401817164 ()


  • Endoscope working-channel valve, single-use
No Description
Zhejiang Chuangxiang Medical Technology Co., LTD.
MD-A-BV02
In Commercial Distribution

  • 16970401817174 ()
  • 06970401817139 ()
  • 26970401817188 ()


  • Endoscope working-channel valve, single-use
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