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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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No Description
Biomet Orthopedics, LLC
110005087
In Commercial Distribution

  • 00880304567634 ()
110005087

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
402283
In Commercial Distribution

  • 00880304560796 ()
402283

  • Orthopaedic cement, antimicrobial
Bracket with Tube Guide
WESTMED, INC.
WP-7704
In Commercial Distribution

  • 10709078013574 ()
  • 00709078013560 ()


  • PEEP valve, single-use
No Description
Biomet Orthopedics, LLC
402439
In Commercial Distribution

  • 00880304476783 ()
402439

  • Orthopaedic cement, antimicrobial
Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic
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
DDS
Not in Commercial Distribution

  • 00865849000204 ()


  • Dental coating, tooth-desensitizing
PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software
The SuperPole F.R.S. (floor receptacle system) with SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole F.R.S. (a support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor). The horizontal bar can be lifted, pivoted, and lowered to the next locking position around the F.R.S. pole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole F.R.S. by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves strong enough for the SuperBar to support the user. When the SuperPole F.R.S. is removed from the concrete receptacle, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight.
Healthcraft Products Inc.
FRS-SPB
In Commercial Distribution

  • 00689281035866 ()
03596

  • Hand rail
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