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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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COULTER EPICS XL Flow Cytometer
Beckman Coulter, Inc.
XL with UPS
In Commercial Distribution

  • 15099590572853 ()
626551

  • Flow cytometry analyser IVD, semi-automated
COULTER EPICS XL-MCL Flow Cytometer
Beckman Coulter, Inc.
XL-MCL with UPS
In Commercial Distribution

  • 15099590572846 ()
626552

  • Flow cytometry analyser IVD, semi-automated
No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
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
No Description
Biomet Orthopedics, LLC
110005089
In Commercial Distribution

  • 00880304567641 ()
110005089

  • Ligament bone anchor
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000QB
In Commercial Distribution

  • D678D5000QB0 ()
  • D678D5000QB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000FB
In Commercial Distribution

  • D678D5000FB0 ()
  • D678D5000FB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
CENTRAL SCREW TA6V Ø4.5mm L.12mm
FX SOLUTIONS
105-4512
In Commercial Distribution

  • 03701037313336 ()
105-4512

  • Shoulder prosthesis screw
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