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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® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.
Urotronic, Inc.
1110
In Commercial Distribution

  • 00853095008297 ()

  • Balloon Diameter: 10 Millimeter
  • Balloon Length: 30 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
1110-10030B

  • Urethral dilatation catheter, drug-eluting
The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.
Urotronic, Inc.
1110
In Commercial Distribution

  • 00853095008273 ()

  • Balloon Diameter: 12 Millimeter
  • Balloon Length: 50 Millimeter
  • Balloon Rated Burst Pressure: 8 Atmosphere
1110-12050B

  • Urethral dilatation catheter, drug-eluting
The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.
Urotronic, Inc.
1110
In Commercial Distribution

  • 00853095008242 ()

  • Balloon Diameter: 12 Millimeter
  • Balloon Length: 30 Millimeter
  • Balloon Rated Burst Pressure: 8 Atmosphere
1110-12030B

  • 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.
1189
In Commercial Distribution

  • 00853095008235 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 35 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1189-30035

  • 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.
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
No Description
VIEWRAY INCORPORATED
23820
In Commercial Distribution

  • 00868029000391 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
0.8 ml, 1.2% OVD Sodium Hyaluronate
Anika Therapeutics, Inc.
6000000
In Commercial Distribution

  • 00866142000052 ()


  • Vitreous/aqueous humour replacement medium, intraoperative
Imagio Breast Imaging System Model 9100
Seno Medical Instruments, Inc.
9100
In Commercial Distribution

  • 00864802000459 ()
9100-000-02

  • Optoacoustic/ultrasound imaging system
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