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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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5% SODIUM FL VARNISH CARAMEL DARBY
DARBY DENTAL SUPPLY, LLC
9510059
In Commercial Distribution

  • 10889813017897 ()
  • 00889813017876 ()
9510059

  • Dental coating, tooth-desensitizing
5% SODIUM FL CLR VARNISH BGUM DARBY
DARBY DENTAL SUPPLY, LLC
9510057
In Commercial Distribution

  • 10889813017866 ()
  • 00889813017845 ()
9510057

  • Dental coating, tooth-desensitizing
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution

  • 00647529000113 ()
  • 00647529000281 ()
7400030

  • Dental coating, tooth-desensitizing
Treatment of dentinal hypersensitivity
SEPTODONT SAS SPECIALITES SEPTODONT
01S0100
In Commercial Distribution

  • 03760140703304 ()

  • Total Volume: 5 Milliliter
01S0100

  • Dental coating, tooth-desensitizing
Pain-Free™-F Desensitizer with Fluoride
PARKELL, INC.
S386
Not in Commercial Distribution

  • M595S3860 ()
S386

  • Dental coating, tooth-desensitizing
No Description
MAXILL, INC.
62189
In Commercial Distribution

  • 00060705621894 ()
  • 90060705621897 ()


  • Dental coating, tooth-desensitizing
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
DREAM FLUORIDE VARNISH CARAMEL..40 ML BOX/50
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
DFVCM
In Commercial Distribution

  • 00817169021476 ()


  • Dental coating, tooth-desensitizing
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