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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 1200 ml.
Coloplast A/S
28037
Not in Commercial Distribution

  • 05708932640664 ()
  • 05708932021500 ()
  • 05708932640657 ()

  • Catheter Gauge: 16 French
  • Length: 40 Centimeter
  • Outer Diameter: 5.3 Millimeter
  • Total Volume: 1200 Milliliter
  • Male
28037

  • Single-administration urethral catheterization kit, single-use
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

  • 05708932615884 ()
  • 05708932615785 ()
  • 05708932021487 ()

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

  • Single-administration urethral catheterization kit, single-use
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 14/4.7 mm. Vol 700 ml.
Coloplast A/S
28032
Not in Commercial Distribution

  • 05708932640619 ()
  • 05708932021371 ()

  • Total Volume: 700 Milliliter
  • Male
  • Outer Diameter: 4.7 Millimeter
  • Length: 40 Centimeter
  • Catheter Gauge: 14 French
28032

  • Single-administration urethral catheterization kit, single-use
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 14/4.7 mm. Vol 700 ml.
Coloplast A/S
28032
Not in Commercial Distribution

  • 05708932640596 ()
  • 05708932021364 ()
  • 05708932640602 ()

  • Outer Diameter: 4.7 Millimeter
  • Length: 40 Centimeter
  • Total Volume: 700 Milliliter
  • Catheter Gauge: 14 French
  • Male
28032

  • Single-administration urethral catheterization kit, single-use
Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X10
In Commercial Distribution

  • 00877234000638 ()

  • Width: 1 Centimeter
  • Length: 10 Centimeter
PFP1X10

  • Cardiovascular patch, animal-derived
RapidPort® EZ Port Applier Tool
ReShape Lifesciences Inc.
C-20390
In Commercial Distribution

C-20390

  • Infusion/injection port/tack applicator
LAP-BAND® AP Adjustable Gastric Banding System Large with RapidPort EZ
ReShape Lifesciences Inc.
C-2365
In Commercial Distribution


  • Large
C-2365

  • Gastric band
LAP-BAND® AP Adjustable Gastric Banding System Standard with RapidPort EZ
ReShape Lifesciences Inc.
C-2360
In Commercial Distribution


  • Standard
C-2360

  • Gastric band
ReShape Lap-Band® 2.0, FLEX Tubing Kit
ReShape Lifesciences Inc.
D-3500
In Commercial Distribution

  • 00850007764586 ()
D-3500

  • Gastric band repair kit
ReShape Lap-Band® 2.0, FLEX & Access Port, Large
ReShape Lifesciences Inc.
D-3306
In Commercial Distribution

  • 00850007764555 ()

  • Large
D-3306

  • Gastric band access port kit
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