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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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Blood Glucose Plus Blood Pressure Monitoring System
FORA CARE INC.
D40d
In Commercial Distribution

  • 00816042011009 ()


  • Home-use/point-of-care glucose rapid test/blood pressure system analyser
InThrill Thrombectomy Catheter (AS-01312)
INARI MEDICAL INC
43-102
In Commercial Distribution

43-102

  • Electronic occlusion spectacles
Super Max Sensitive Skin Lice Elimination Kit
Oystershell Consumer Health, Inc
02100298/80028
In Commercial Distribution

  • 00810061048282 ()


  • Lice removal/prevention kit
Super Max Advanced Shampoo Lice Elimination Kit
Oystershell Consumer Health, Inc
02060165/80027
In Commercial Distribution

  • 00810061048275 ()


  • Lice removal/prevention kit
Super Max Complete Lice Elimination Kit
Oystershell Consumer Health, Inc
02200008/80026
In Commercial Distribution

  • 00810061048268 ()


  • Lice removal/prevention kit
Super Max Sensitive Skin Lice Elimination Kit
Oystershell Consumer Health, Inc
02100297/80014X
In Commercial Distribution

  • 00810061048145 ()


  • Lice removal/prevention kit
Super Max Complete Lice Elimination Kit
Oystershell Consumer Health, Inc
02200005/80013
In Commercial Distribution

  • 00810061048138 ()


  • Lice removal/prevention kit
Super Max Lice Elimination Kit
Oystershell Consumer Health, Inc
02100260/80011
In Commercial Distribution

  • 00810061048114 ()


  • Lice removal/prevention kit
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
Universal Dentin Sealant Mini Kit Universal
ULTRADENT PRODUCTS, INC.
1020
Not in Commercial Distribution

  • 00883205104014 ()
1020

  • Dental coating, tooth-desensitizing
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