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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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SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 16/5.3 mm. Vol 700 ml.
Coloplast A/S
28033
Not in Commercial Distribution

  • 05708932640633 ()
  • 05708932640626 ()

  • Outer Diameter: 5.3 Millimeter
  • Length: 40 Centimeter
  • Catheter Gauge: 16 French
  • Total Volume: 700 Milliliter
  • Male
28033

  • Single-administration urethral catheterization kit, single-use
SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coated catheter. Length 3.25 in. FR 12/4.0 mm. Rx only.
Coloplast A/S
28112
Not in Commercial Distribution

  • 05708932618724 ()
  • 05708932618748 ()
  • 05708932618731 ()

  • Female
  • Outer Diameter: 4 Millimeter
  • Length: 3.25 Inch
  • Catheter Gauge: 12 French
28112

  • Single-administration urethral drainage catheter
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 14/4.7 mm. Vol 1200 ml.
Coloplast A/S
28036
Not in Commercial Distribution

  • 05708932640640 ()
  • 05708932618250 ()

  • Catheter Gauge: 14 French
  • Male
  • Outer Diameter: 4.7 Millimeter
  • Total Volume: 1200 Milliliter
  • Length: 40 Centimeter
28036

  • Single-administration urethral catheterization kit, single-use
SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. FR 12/4.0-18/6.0 mm. Rx Only.
Coloplast A/S
28692
Not in Commercial Distribution

  • 05708932579018 ()
  • 05708932579032 ()
  • 05708932579025 ()

  • Outer catheter FR 18/6.0 mm
  • Catheter Gauge: 12 French
  • Outer Diameter: 4 Millimeter
  • Inner catheter FR 12/4.0 mm
  • Male
28692

  • Single-administration urethral drainage catheter
Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X10
In Commercial Distribution

  • 00877234000638 ()

  • Width: 1 Centimeter
  • Length: 10 Centimeter
PFP1X10

  • Cardiovascular patch, animal-derived
Vertessa Lite Y 26x5x4cm polypropylene mesh for sacrocolpopexy
Caldera Medical, Inc.
CAL-VLY2654
In Commercial Distribution

  • 00890594000773 ()
  • 00890594000797 ()
  • 00890594000780 ()

  • 26 x 5 x 4cm


  • Pelvic organ prolapse surgical mesh, composite-polymer
LAP-BAND® Access Port Needle 3.5 inch Pouch
ReShape Lifesciences Inc.
B-20301-10
In Commercial Distribution

  • 10850007764330 ()
  • 10811955020411 ()
  • 00850007764333 ()
B-20301-10

  • Subcutaneous infusion/injection port needle
LAP-BAND® Access Port Needle 2 inch Pouch
ReShape Lifesciences Inc.
B-20302-10
In Commercial Distribution

  • 10850007764323 ()
  • 10811955020428 ()
  • 00850007764326 ()
B-20302-10

  • Subcutaneous infusion/injection port needle
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

  • 00853095008334 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 50 Millimeter
  • Balloon Rated Burst Pressure: 12 Atmosphere
1110-06050B

  • 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

  • 00853095008327 ()

  • Balloon Diameter: 8 Millimeter
  • Balloon Length: 50 Millimeter
  • Balloon Rated Burst Pressure: 12 Atmosphere
1110-08030B

  • Urethral dilatation catheter, drug-eluting
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