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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 - 00801741122767

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm 5 French
LUTONIX, INC.
LX357541005F
Not in Commercial Distribution

  • 00801741122767 ()

  • Catheter Length, 75 Centimeter
  • Balloon Length, 100 Millimeter
  • Balloon Diameter, 4 Millimeter
LX357541005F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122750

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French
LUTONIX, INC.
LX35754805F
Not in Commercial Distribution

  • 00801741122750 ()

  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 80 Millimeter
  • Catheter Length, 75 Centimeter
LX35754805F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122743

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
LX35754605F
Not in Commercial Distribution

  • 00801741122743 ()

  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
  • Balloon Length, 60 Millimeter
LX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon - 00801741122736

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
LX35754405F
Not in Commercial Distribution

  • 00801741122736 ()

  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 75 Centimeter
LX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502053846

Black, 8cm (3")
COCHLEAR LIMITED
P1749665
In Commercial Distribution

  • 09321502053846 ()

  • 8 cm long cable
  • Length: 8 Centimeter
P1749665

  • Cochlear implant/auditory brainstem implant coil

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502053631

Sand, 6cm (2 1/2")
COCHLEAR LIMITED
P1749644
In Commercial Distribution

  • 09321502053631 ()

  • Length: 6 Centimeter
  • 6 cm long cable
P1749644

  • Cochlear implant/auditory brainstem implant coil

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502053617

Brown, 6cm (2 1/2")
COCHLEAR LIMITED
P1749642
In Commercial Distribution

  • 09321502053617 ()

  • 6 cm long cable
  • Length: 6 Centimeter
P1749642

  • Cochlear implant/auditory brainstem implant coil

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502054256

Silver, 25cm (10")
COCHLEAR LIMITED
P1749706
In Commercial Distribution

  • 09321502054256 ()

  • Length: 25 Centimeter
  • 25 cm long cable
P1749706

  • Cochlear implant/auditory brainstem implant coil

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502054249

White, 25cm (10")
COCHLEAR LIMITED
P1749705
In Commercial Distribution

  • 09321502054249 ()

  • 25 cm long cable
  • Length: 25 Centimeter
P1749705

  • Cochlear implant/auditory brainstem implant coil

Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) - 09321502054232

Sand, 25cm (10")
COCHLEAR LIMITED
P1749704
In Commercial Distribution

  • 09321502054232 ()

  • 25 cm long cable
  • Length: 25 Centimeter
P1749704

  • Cochlear implant/auditory brainstem implant coil
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