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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® 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

  • 00853095008280 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 30 Millimeter
  • Balloon Rated Burst Pressure: 12 Atmosphere
1110-06030B

  • Urethral dilatation catheter, drug-eluting
BIRMINGHAM HIP DYSPLASIA SCREW SOCKET
Smith & Nephew, Inc.
90127568
In Commercial Distribution

  • 03596010533586 ()
90127568

  • Surgical screwdriver, reusable
DRIVER 2-2003 HEX TORQUE LIM X STOP EU
MEDTRONIC SOFAMOR DANEK, INC.
2-2003
In Commercial Distribution

  • 00843889000200 ()


  • Surgical screwdriver, reusable
DRIVER 2-2003 HEX TORQUE LIM X STOP US
MEDTRONIC SOFAMOR DANEK, INC.
2-2003
In Commercial Distribution

  • 00613994455475 ()


  • Surgical screwdriver, reusable
DRIVER 2-2003 HEX TORQUE LIM X STOP US
MEDTRONIC SOFAMOR DANEK, INC.
2-2003
In Commercial Distribution

  • 00613994598578 ()


  • Surgical screwdriver, reusable
DRIVER 2-2003 HEX TRORQUE LIM X STOP US
MEDTRONIC SOFAMOR DANEK, INC.
2-2003
In Commercial Distribution

  • 00643169117747 ()


  • Surgical screwdriver, reusable
The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system
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