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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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The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1189
In Commercial Distribution

  • 00853095008181 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 30 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1189-30030

  • Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution

  • 00853095008174 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 40 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1113-30040

  • Urethral dilatation catheter, drug-eluting
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1113
In Commercial Distribution

  • 00853095008129 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 35 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1113-30035

  • Urethral dilatation catheter, drug-eluting
RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0105
In Commercial Distribution

  • 00851707004361 ()


  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 480
In Commercial Distribution

  • 00851707004262 ()
AVRL0102

  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004200 ()
AVRL0101

  • Autologous skin cell grafting kit
RECELL Autologous Cell Harvesting Device
AVITA MEDICAL AMERICAS, LLC
US 1920
In Commercial Distribution

  • 00851707004149 ()
C3RL01-B:US

  • Autologous skin cell grafting kit
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-6-40
In Commercial Distribution

  • 00851616007651 ()
NG-NV-6-40

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-6-30
In Commercial Distribution

  • 00851616007644 ()
NG-NV-6-30

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent
The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-NV-7-30
In Commercial Distribution

  • 00851616007637 ()
NG-NV-7-30

  • Peripheral angioplasty balloon catheter, basic
  • Bare-metal carotid artery stent
  • Carotid artery embolic protection system
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