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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 - 00801741177033

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X80MMX75CM
LUTONIX, INC.
LX18755805F
In Commercial Distribution

  • 00801741177033 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
LX18755805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177026

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X60MMX75CM
LUTONIX, INC.
LX18755605F
In Commercial Distribution

  • 00801741177026 ()

  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Length, 60 Millimeter
LX18755605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741177019

LUTONIX® 018 Drug Coated Balloon PTA Catheter 5X40MMX75CM
LUTONIX, INC.
LX18755405F
In Commercial Distribution

  • 00801741177019 ()

  • Balloon Diameter, 5 Millimeter
  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
LX18755405F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741163418

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® Drug Coated Balloon - 00801741098468

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm
LUTONIX, INC.
BSCLX35130580
Not in Commercial Distribution

  • 00801741098468 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 80 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098451

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm
LUTONIX, INC.
BSCLX35130560
Not in Commercial Distribution

  • 00801741098451 ()

  • Catheter Length, 130 Centimeter
  • Balloon Length, 60 Millimeter
  • Balloon Diameter, 5 Millimeter
BSCLX35130560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098444

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm
LUTONIX, INC.
BSCLX35130540
Not in Commercial Distribution

  • 00801741098444 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 5 Millimeter
  • Catheter Length, 130 Centimeter
BSCLX35130540

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098437

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x100mm
LUTONIX, INC.
BSCLX351305100
Not in Commercial Distribution

  • 00801741098437 ()

  • Balloon Length, 100 Millimeter
  • Catheter Length, 130 Centimeter
  • Balloon Diameter, 5 Millimeter
BSCLX351305100

  • Peripheral angioplasty balloon catheter, drug-coated

X SERIES - 00847946005788

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST
Zoll Medical Corporation
610-0241511-01
In Commercial Distribution

  • 00847946005788 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator

X SERIES - 00847946005764

Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACING, NIBP, SPO2, SPCO, SPMET, TEMP CPR EXPANSION PACK AND ETCO2, DMST, DMST
Zoll Medical Corporation
610-0241411-01
In Commercial Distribution

  • 00847946005764 ()

  • 8.9" x 10.4" x 8.75"


  • Rechargeable professional automated external defibrillator
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