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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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Enamelast Unit Dose 5pk - Walterberry
ULTRADENT PRODUCTS, INC.
4526
In Commercial Distribution

  • 00883205101754 ()
4526

  • Dental coating, tooth-desensitizing
Enamelast 200pk Application Brushes
ULTRADENT PRODUCTS, INC.
4529
In Commercial Distribution

  • 00883205021533 ()
4529

  • Dental coating, tooth-desensitizing
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 10mL
In Commercial Distribution

  • 00850362007106 ()

  • Total Volume: 10 Milliliter
10-1018

  • Dental coating, tooth-desensitizing
Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 3mL
In Commercial Distribution

  • 00850362007090 ()

  • Total Volume: 3 Milliliter
10-1016

  • Dental coating, tooth-desensitizing
Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Complete Desensitizer - 5mL
In Commercial Distribution

  • 00850362007083 ()

  • Total Volume: 5 Milliliter
10-1017

  • Dental coating, tooth-desensitizing
KöR Teeth Desensitizer - 5ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Teeth Desensitizer - 5ml
In Commercial Distribution

  • 00850362007076 ()

  • Total Volume: 5 Milliliter
10-1012

  • Dental coating, tooth-desensitizing
KöR Teeth Desensitizer - 2.5ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Teeth Desensitizer - 2.5ml
In Commercial Distribution

  • 00850362007069 ()

  • Total Volume: 2.5 Milliliter
10-1011

  • Dental coating, tooth-desensitizing
KöR Desensitizer-10ml
EVOLVE DENTAL TECHNOLOGIES, INC.
KöR Desensitizer-10ml
In Commercial Distribution

  • 00850362007052 ()

  • Total Volume: 10 Milliliter
10-1010

  • 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
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