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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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No Description
LOOCID LLC
UNI-BB-30-R
In Commercial Distribution

  • 80860011925954 ()
  • 00860011925965 ()


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-20
In Commercial Distribution

  • 00860011925934 ()

  • Outer Diameter: 2.0 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-42-R
In Commercial Distribution

  • 80850055961933 ()
  • 00860011925927 ()

  • Outer Diameter: 4.2 Millimeter


  • Fluted surgical drill bit, reusable
No Description
LOOCID LLC
UNI-BB-32-R
In Commercial Distribution

  • 80850055961926 ()
  • 00860011925903 ()

  • Outer Diameter: 3.2 Millimeter


  • Fluted surgical drill bit, reusable
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material
Valley Contax, Inc.
Optimum Extreme (roflufocon E) Clear
In Commercial Distribution

  • 00860011844136 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Light Blue material
Valley Contax, Inc.
Optimum Extreme (roflufocon E) Light Blue
In Commercial Distribution

  • 00860011844129 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
Rigid Gas Permeable Scleral Contact Lens for Daily Wear
Valley Contax, Inc.
Optimum Exra (roflufocon D) Clear
In Commercial Distribution

  • 00860011844112 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.
VisionAir Solutions, LLC
1
In Commercial Distribution

0010-0126

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
Coloplast Irrigation set. 1 Water bag, 1 Irrigation cone.
Coloplast A/S
01500
In Commercial Distribution

  • 05708932611725 ()
  • 05708932611718 ()
01500

  • Colostomy irrigation kit, reusable
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