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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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SUPERA - 08717648211874

Supera Peripheral Stent System 5 mm x 30 mm x 120 cm 6 F
ABBOTT VASCULAR INC.
S-50-030-120-P6
In Commercial Distribution

  • 08717648211874 ()
S-50-030-120-P6

  • Peripheral artery stent, bare-metal

SUMMIT POROCOAT - 10603295060062

SUMMIT FEMORAL STEM 12/14 TAPER TAPER ED w/POROCOAT SIZE 5 HI 145mm
DEPUY ORTHOPAEDICS, INC.
1570-11-110
In Commercial Distribution

  • 10603295060062 ()
157011110

  • Coated femoral stem prosthesis, one-piece

SUMMIT POROCOAT - 10603295059363

SUMMIT FEMORAL STEM 12/14 TAPER TAPER ED w/POROCOAT SIZE 5 STD 145mm
DEPUY ORTHOPAEDICS, INC.
1570-01-110
In Commercial Distribution

  • 10603295059363 ()
157001110

  • Coated femoral stem prosthesis, one-piece

LUTONIX® Drug Coated Balloon - 00801741123924

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French
LUTONIX, INC.
BSLX351307605F
Not in Commercial Distribution

  • 00801741123924 ()

  • Balloon Diameter, 7 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 130 centimeter
BSLX351307605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123917

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French
LUTONIX, INC.
BSLX351307405F
Not in Commercial Distribution

  • 00801741123917 ()

  • Balloon Diameter, 7 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 40 millimeter
BSLX351307405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123900

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French
LUTONIX, INC.
BSLX3513061505F
Not in Commercial Distribution

  • 00801741123900 ()

  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Length, 150 millimeter
BSLX3513061505F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123894

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French
LUTONIX, INC.
BSLX3513061205F
Not in Commercial Distribution

  • 00801741123894 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 120 millimeter
  • Catheter Length, 130 centimeter
BSLX3513061205F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123887

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm 5 French
LUTONIX, INC.
BSLX3513061005F
Not in Commercial Distribution

  • 00801741123887 ()

  • Balloon Diameter, 6 millimeter
  • Balloon Length, 100 millimeter
  • Catheter Length, 130 centimeter
BSLX3513061005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123870

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x80mm 5 French
LUTONIX, INC.
BSLX351306805F
Not in Commercial Distribution

  • 00801741123870 ()

  • Balloon Length, 80 millimeter
  • Catheter Length, 130 centimeter
  • Balloon Diameter, 6 millimeter
BSLX351306805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741123863

BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm 5 French
LUTONIX, INC.
BSLX351306605F
Not in Commercial Distribution

  • 00801741123863 ()

  • Balloon Length, 60 millimeter
  • Balloon Diameter, 6 millimeter
  • Catheter Length, 130 centimeter
BSLX351306605F

  • Peripheral angioplasty balloon catheter, drug-coated
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