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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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ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 18MM
DEPUY (IRELAND)
1517-11-018
In Commercial Distribution

  • 10603295056515 ()
151711018

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 16MM
DEPUY (IRELAND)
1517-11-016
In Commercial Distribution

  • 10603295056508 ()
151711016

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 14MM
DEPUY (IRELAND)
1517-11-014
In Commercial Distribution

  • 10603295056492 ()
151711014

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 12MM
DEPUY (IRELAND)
1517-11-012
In Commercial Distribution

  • 10603295056485 ()
151711012

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 10MM
DEPUY (IRELAND)
1517-11-010
In Commercial Distribution

  • 10603295056478 ()
151711010

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 8MM
DEPUY (IRELAND)
1517-11-008
In Commercial Distribution

  • 10603295056461 ()
151711008

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 10 6MM
DEPUY (IRELAND)
1517-11-006
In Commercial Distribution

  • 10603295056454 ()
151711006

  • Tibial insert
ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT UNIVERSAL 5MM CEMENTED SIZE 9/10
DEPUY (IRELAND)
1523-09-001
In Commercial Distribution

  • 10603295057697 ()
152309001

  • Knee arthroplasty wedge
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

  • 00853095008310 ()

  • Balloon Diameter: 10 Millimeter
  • Balloon Length: 50 Millimeter
  • Balloon Rated Burst Pressure: 10 Atmosphere
1110-10050B

  • 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

  • 00853095008297 ()

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

  • Urethral dilatation catheter, drug-eluting
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