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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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SMART DENTURE CONVERSIONS, LLC
AD
In Commercial Distribution

  • D990AD0 ()


  • Steel dental bur, reusable
A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.
GULF FIBEROPTICS, INC.
4.6mm bundle diameter, 9.9' length, Bifurcated Cable
In Commercial Distribution

  • 00857580006744 ()
169-500-S

  • Surgical instrument fibreoptic light
A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.
GULF FIBEROPTICS, INC.
4.6mm bundle diameter, 10' length, Bifurcated Cable
In Commercial Distribution

  • 00857580006720 ()
27436-3-S

  • Surgical instrument fibreoptic light
Guide wire and surgical instrument organizational tray
AHN SURGICAL INNOVATION, LLC
TR231
In Commercial Distribution

  • 00860009955509 ()


  • General-purpose bowl, single-use
Men's Liberty for iMEDicare, (box of 30)
ARGENTUM MEDICAL, LLC
23046-30UK
In Commercial Distribution

  • 10653599002251 ()
  • 00653599002254 ()


  • Penis wearable urinal
Men's Liberty for iMEDicare, (pack of 4)
ARGENTUM MEDICAL, LLC
23046-4
In Commercial Distribution

  • 10653599001797 ()
  • 00653599001790 ()


  • Penis wearable urinal
Faceplate Seal for iMEDicare (pack of 10)
ARGENTUM MEDICAL, LLC
20002UK
In Commercial Distribution

  • 00653599001684 ()


  • Dressing-fixation skin adhesive tape, non-silicone
Men's Liberty for iMEDicare, (pack of 10)
ARGENTUM MEDICAL, LLC
23046-10
In Commercial Distribution

  • 10653599001674 ()
  • 00653599001677 ()


  • Penis wearable urinal
Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.
ADVANTAGE DENTAL PRODUCTS INC
120
Not in Commercial Distribution

  • 10859787002106 ()
  • 00859787002109 ()
  • 00859787002192 ()


  • Dental impression tray, single-use
Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression materials.
ADVANTAGE DENTAL PRODUCTS INC
118
Not in Commercial Distribution

  • 10859787002090 ()
  • 00859787002093 ()
  • 00859787002215 ()


  • Dental impression tray, single-use
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