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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-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
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
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide
Dev4
CT-2000NS
In Commercial Distribution

  • 00860011634829 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Carpal Tunnel Release, (1) SurePass CTR Guide, (1) SurePass CTR Knife Blade
Dev4
CT-1000
In Commercial Distribution

  • 00860011634812 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
Small Bone Extraction Tool
Dev4
TP-1000
In Commercial Distribution

  • 00860011634805 ()


  • Bone curette, single-use
SPINERY Generator (REF: SPINERY) is a RadioFrequency Generator used for parameter control and treatment modulation; equipped with a peristaltic pump intended to allow the flow of a close cooling fluid (sterile saline water) inside RF electrode needles during ablation procedure. A Footswitch, used to control the activation and interruption of the ablation, is provided together with the Generator. A Stainless-Steel rod is also provided to hang up the sterile water bag for used for cooling system circuit.
AXON SRL
SPINERY
In Commercial Distribution

  • 00860011603665 ()


  • Percutaneous radio-frequency ablation system generator
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4NS
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
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