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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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The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.
Ulab Systems, Inc.
FG0010
In Commercial Distribution

  • 00860461001790 ()


  • Orthodontic progressive aligner
No Description
Sonoma Pharmaceuticals, Inc.
85014
In Commercial Distribution

  • 20860452000386 ()
  • 00860452000382 ()

  • Total Volume: 15 Milliliter
85014

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
85021
In Commercial Distribution

  • 20860452000379 ()
  • 00860452000375 ()

  • Weight: 170 Gram
85021

  • Wound hydrogel dressing, non-antimicrobial
No Description
Sonoma Pharmaceuticals, Inc.
85020
In Commercial Distribution

  • 20860452000362 ()
  • 00860452000368 ()

  • Weight: 14 Gram
85020

  • Wound hydrogel dressing, non-antimicrobial
No Description
Sonoma Pharmaceuticals, Inc.
85019
In Commercial Distribution

  • 20860452000355 ()
  • 00860452000351 ()

  • Weight: 170 Gram
85019

  • Wound hydrogel dressing, non-antimicrobial
No Description
Sonoma Pharmaceuticals, Inc.
85013
In Commercial Distribution

  • 20860452000331 ()
  • 00860452000337 ()

  • Total Volume: 237 Milliliter
85013

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
85012
In Commercial Distribution

  • 20860452000324 ()
  • 00860452000320 ()

  • Total Volume: 473 Milliliter
85012

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
84871
In Commercial Distribution

  • 20860439002099 ()
  • 00860439002095 ()
  • 10860439002092 ()

  • Total Volume: 59 Milliliter
84871

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
85048
In Commercial Distribution

  • 20860439002082 ()
  • 00860439002088 ()

  • Total Volume: 15 Milliliter
85048

  • Non-antimicrobial wound irrigation solution, multiple solute
No Description
Sonoma Pharmaceuticals, Inc.
85047
In Commercial Distribution

  • 20860439002075 ()
  • 00860439002071 ()

  • Total Volume: 237 Milliliter
85047

  • Non-antimicrobial wound irrigation solution, multiple solute
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