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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 GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)
HMD BIOMEDICAL INC.
AC11-NFC
Not in Commercial Distribution

  • 04711200721850 ()
  • 04711200722154 ()
3K-01-16003G

  • Home-use/point-of-care blood glucose/blood pressure monitoring system
Mal Ear Mop
EXMOOR PLASTICS LIMITED
E.301CM
In Commercial Distribution

  • 05060180253158 ()
  • 05060180258740 ()
E301CM

  • Cotton bud
Mal Ear Mop
EXMOOR PLASTICS LIMITED
E.301
In Commercial Distribution

  • 05060180251925 ()
  • 05060180256159 ()
E301

  • Cotton bud
Garth Nasal Mop
EXMOOR PLASTICS LIMITED
E.302
In Commercial Distribution

  • 05060180251932 ()
  • 05060180252083 ()
E.302

  • Cotton bud
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000242 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000228 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
G6
Not in Commercial Distribution

  • 00865849000211 ()

  • Total Volume: 5 Milliliter


  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
DDS
Not in Commercial Distribution

  • 00865849000204 ()


  • Dental coating, tooth-desensitizing
50 single dose dispensers / 0.1mL each dental desensitizer with 4% chlorhexadine
ADVANTAGE DENTAL PRODUCTS INC
180
In Commercial Distribution

  • 10859787002045 ()
  • 00859787002048 ()
  • 00859787002130 ()

  • Total Volume: 0.1 Milliliter


  • Dental coating, tooth-desensitizing
10mL bottle - dental desensitizer with 4% chlorhexadine
ADVANTAGE DENTAL PRODUCTS INC
170
In Commercial Distribution

  • 10859787002007 ()
  • 00859787002000 ()

  • Total Volume: 10 Milliliter


  • Dental coating, tooth-desensitizing
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