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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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PREVENTI- BIODEGRADABLE POWDER-FREE NITRILE EXAM GLOVES-X-SMALL
Rushmedics LLC
PRB1940
In Commercial Distribution

  • 10850046528009 ()
  • 00850046528002 ()
  • 20850046528006 ()
PRB1940

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Oral Hygiene Kit
Oralkleen, LLC
V1.1
In Commercial Distribution

  • 00850030081056 ()
615-0110

  • Oral care kit, reusable
Oral Hygiene Kit
Oralkleen, LLC
V1
Not in Commercial Distribution

  • 10850030081015 ()
  • 00850030081018 ()
615-0100

  • Oral care kit, reusable
rapid urine test for the semi-quantitative measurement of nicotine and nicotine metabolites
Mossman Associates, Inc.
1
In Commercial Distribution

  • 00860007588907 ()
500-001

  • Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical
Magic Wand® Micro HV-60, personal hand-held electronic massage apparatus, variable speed.
VIBRATEX, INC.
Micro HV-60
In Commercial Distribution

  • 10860003633820 ()
  • 00860003633823 ()


  • Hand-held electric massager
Magic Wand® Mini HV-135, personal hand-held electronic massage apparatus, variable speed.
VIBRATEX, INC.
Mini HV-135
In Commercial Distribution

  • 10860003633806 ()
  • 00860003633809 ()


  • Hand-held electric massager
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
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
DXR, Dentsply Sirona - XiVE Ø5.5
In Commercial Distribution

  • 05744003810307 ()
80610207

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
DXB, Dentsply Sirona - XiVE Ø4.5
In Commercial Distribution

  • 05744003810291 ()
80610206

  • Dental implant abutment analog, intraoral-scanning, single-use
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