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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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Nitrile Exam Glove with Aloe, Green, Small
Dash Medical Gloves, Inc.
NA100S
In Commercial Distribution

  • 00649531420729 ()
  • 00649531320722 ()
  • 00649531320029 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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
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
DDS
Not in Commercial Distribution

  • 00865849000204 ()


  • 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
No Description
HILL LABORATORIES CO.
Air Flex II with Auto-Distraction
In Commercial Distribution

  • 00860001452525 ()


  • Body arch traction table
No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0651
Not in Commercial Distribution

  • 10607915114944 ()
  • 00607915114947 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 11 Millimeter


  • Laparoscopic access cannula, single-use
BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 53600
In Commercial Distribution

  • 00607567209978 ()
709000218

  • Cardiopulmonary bypass system blood tubing set
Softshell venous reservoir 1900 BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 21308
Not in Commercial Distribution

  • 00607567207141 ()
701068376

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BEQ-T 8068
In Commercial Distribution

  • 00607567206113 ()
701066883

  • Cardiopulmonary bypass system blood tubing set
BEQ HMOD 30000 Blood Transfer Bag Better Bladder Blood Microfilter System Cardiopegia Filter Gas Filter Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 24105
Not in Commercial Distribution

  • 00607567205574 ()
701064757

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000 Soft Shell Venous Reser 800 ml Better Bladder 1/4 CDI Set Cell 1/4 system 100 Blood Microfilter system Prebypass filter Gas Filter Temperature Proble
DATASCOPE CORP.
BEQ-TOP 22702
Not in Commercial Distribution

  • 00607567202573 ()
701051179

  • Cardiopulmonary bypass system blood tubing set
Reusable Probes with holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6204
Not in Commercial Distribution

  • 00607915117078 ()

  • Length: 33 Centimeter
  • Outer Diameter: 10 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
Laparoscopic Trocar Sleeve
APPLIED MEDICAL RESOURCES CORPORATION
C0652
Not in Commercial Distribution

  • 10607915114951 ()
  • 00607915114954 ()

  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 12 Millimeter


  • Laparoscopic access cannula, single-use
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
angled, distal opening on top 2.5 mm, 25 cm
Spiggle & Theis Medizintechnik GmbH
50-347-25-L
In Commercial Distribution

  • 04250676742636 ()
50-347-25-L

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
No Description
Noras MRI products GmbH
13
In Commercial Distribution

  • 04251269201516 ()
113120

  • MRI system coil, radio-frequency
AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
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