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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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Closed Tray Impression Coping Straight Transfer Abutment L - 2mm
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237319 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Open Tray Impression Coping Standard Open Transfer 13mm
IMPLANT CLUB, INC
1
In Commercial Distribution

  • 00860012237302 ()
ST13

  • Dental implant suprastructure, temporary, preformed, single-use
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
No Description
SPIRAIR, INC.
FG-0032
In Commercial Distribution

  • 00860011696315 ()
SPLN005

  • Nasal cartilage support implant, bioabsorbable
  • Nasal cartilage support implant introducer
No Description
SPIRAIR, INC.
FG-0032
In Commercial Distribution

  • 00860011696308 ()
SPLN001

  • Nasal cartilage support implant, bioabsorbable
  • Nasal cartilage support implant introducer
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-5M
In Commercial Distribution

  • 00860011485445 ()
  • M748PL5M0 ()


  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4NS
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-4
In Commercial Distribution

  • 00860011485421 ()
  • M748PL40 ()


  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-3
In Commercial Distribution

  • 00860011485414 ()
  • M748PL30 ()


  • Manual brachytherapy source, permanent implant
No Description
GT MEDICAL TECHNOLOGIES, INC.
PL-2
In Commercial Distribution

  • 00860011485407 ()
  • M748PL20 ()


  • Manual brachytherapy source, permanent implant
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