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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 Syringe 20pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4347
Not in Commercial Distribution

  • 00883205102812 ()
4347

  • Dental coating, tooth-desensitizing
Enamelast Syringe 2pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4346
Not in Commercial Distribution

  • 00883205102805 ()
4346

  • Dental coating, tooth-desensitizing
Enamelast Unit Dose 5pk - Orange Cream
ULTRADENT PRODUCTS, INC.
4345
In Commercial Distribution

  • 00883205102799 ()
4345

  • Dental coating, tooth-desensitizing
UltraEZ Tray Delivery, Upper/Lower Combo Kit
ULTRADENT PRODUCTS, INC.
5721
In Commercial Distribution

  • 00883205102690 ()
5721

  • Dental coating, tooth-desensitizing
UltraEz Mini Kit
ULTRADENT PRODUCTS, INC.
5743
In Commercial Distribution

  • 00883205102652 ()
5743

  • Dental coating, tooth-desensitizing
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
No Description
BURKHART DENTAL SUPPLY CO., THE
72722204
In Commercial Distribution

  • 00854212006790 ()
  • 00854212006837 ()


  • Dental coating, tooth-desensitizing
No Description
BURKHART DENTAL SUPPLY CO., THE
72722203
In Commercial Distribution

  • 00854212006783 ()
  • 00854212006820 ()


  • Dental coating, tooth-desensitizing
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