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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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Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 15 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 30 spheres.
Northern Digital Inc
8800966
In Commercial Distribution

  • 20805832030034 ()
  • 00805832030030 ()
8800966

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 12 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 24 spheres.
Northern Digital Inc
8800967
In Commercial Distribution

  • 20805832030027 ()
  • 00805832030023 ()
8800967

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 9 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 18 spheres.
Northern Digital Inc
8800965
In Commercial Distribution

  • 20805832030010 ()
  • 00805832030016 ()
8800965

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres.
Northern Digital Inc
8801002
In Commercial Distribution

  • 20805832020042 ()
  • 00805832020048 ()
8801002

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.
Northern Digital Inc
8801054
In Commercial Distribution

  • 00805832020031 ()
  • 20805832020035 ()
8801054

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 36 spheres.
Northern Digital Inc
8801053
In Commercial Distribution

  • 00805832020024 ()
  • 20805832020028 ()
8801053

  • Imaging lesion localization marker, external, single-use
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres.
Northern Digital Inc
8801051
In Commercial Distribution

  • 00805832020017 ()
  • 20805832020011 ()
8801051

  • Imaging lesion localization marker, external, single-use
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
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
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