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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 - 00801741135064

Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x40
LUTONIX, INC.
LX3540460V
Not in Commercial Distribution

  • 00801741135064 ()

  • Catheter Length, 40 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 60 millimeter
LX3540460V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135057

Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x40
LUTONIX, INC.
LX3540440V
Not in Commercial Distribution

  • 00801741135057 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
LX3540440V

  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030449

SurVeil DCB 5.0mm x 150mm x 135cm
Surmodics, Inc.
SRV03513505015
In Commercial Distribution

  • 00812339030449 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Diameter: 150 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

SPRINT QUATTRO® - 00643169451476

LEAD 6944-100 SPRINT QUATTRO US
MEDTRONIC, INC.
6944-100
Not in Commercial Distribution

  • 00643169451476 ()

  • Length: 100.0 Centimeter


  • Endocardial defibrillation lead

SPRINT QUATTRO® - 00643169451469

LEAD 6944-65 SPRINT QUATTRO US
MEDTRONIC, INC.
6944-65
Not in Commercial Distribution

  • 00643169451469 ()

  • Length: 65.0 Centimeter


  • Endocardial defibrillation lead

SPRINT QUATTRO® - 00643169451452

LEAD 6944-75 SPRINT QUATTRO US
MEDTRONIC, INC.
6944-75
Not in Commercial Distribution

  • 00643169451452 ()

  • Length: 75.0 Centimeter


  • Endocardial defibrillation lead

SPRINT QUATTRO® - 00643169440852

LEAD 6944-58 SPRINT QUATTRO US
MEDTRONIC, INC.
6944-58
Not in Commercial Distribution

  • 00643169440852 ()

  • Length: 58.0 Centimeter


  • Endocardial defibrillation lead

Sprint Quattro Secure MRI™ SureScan™ - 00643169356627

LEAD 6947M62 QUATTRO SECURE MRI US
MEDTRONIC, INC.
6947M62
In Commercial Distribution

  • 00643169356627 ()

  • Length: 62.0 Centimeter


  • Endocardial defibrillation lead

Sprint Quattro Secure MRI™ SureScan™ - 00643169356610

LEAD 6947M55 QUATTRO SECURE MRI US
MEDTRONIC, INC.
6947M55
In Commercial Distribution

  • 00643169356610 ()

  • Length: 55.0 Centimeter


  • Endocardial defibrillation lead

Sprint Quattro Secure S MRI™ SureScan™ - 00643169356566

LEAD 6935M62 QUATTRO SECURE S MRI US
MEDTRONIC, INC.
6935M62
In Commercial Distribution

  • 00643169356566 ()

  • Length: 62.0 Centimeter


  • Endocardial defibrillation lead
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