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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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Zilver 518 Vascular Stent
COOK IRELAND LTD
G43771
In Commercial Distribution

  • 10827002437712 ()
ZIV5-18-125-6-40

  • Peripheral artery stent, bare-metal
Zilver 518 Vascular Stent
COOK IRELAND LTD
G43770
In Commercial Distribution

  • 10827002437705 ()
ZIV5-18-125-6-30

  • Peripheral artery stent, bare-metal
Zilver 518 Vascular Stent
COOK IRELAND LTD
G43769
In Commercial Distribution

  • 10827002437699 ()
ZIV5-18-125-6-20

  • Peripheral artery stent, bare-metal
BONE TAMP KIT KEX102NB AF E2 10/2
MEDTRONIC SOFAMOR DANEK, INC.
KEX102NB
In Commercial Distribution

  • 00763000026905 ()


  • Balloon kyphoplasty kit
No Description
TORAY INDUSTRIES,INC.
PTMC-28
In Commercial Distribution

  • 14960685200047 ()

  • Balloon Diameter Range: 24-28 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
No Description
TORAY INDUSTRIES,INC.
PTMC-26
In Commercial Distribution

  • 14960685200030 ()

  • Balloon Diameter Range: 22-26 Millimeter
  • Catheter Gauge: 12 French
  • Length: 70 Centimeter


  • Cardiac valvuloplasty catheter
BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system.
BECTON, DICKINSON AND COMPANY
491087
In Commercial Distribution

  • 00382904910877 ()

  • Length: 29 Inch
  • Width: 33.5 Inch
  • Height: 33.5 Inch
491087

  • Cell morphology analyser IVD, manual
BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system.
BECTON, DICKINSON AND COMPANY
491086
Not in Commercial Distribution

  • 00382904910860 ()

  • Height: 33.5 Inch
  • Width: 33.5 Inch
  • Length: 29 Inch
491086

  • Cell morphology analyser IVD, manual
BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system.
BECTON, DICKINSON AND COMPANY
491085
In Commercial Distribution

  • 00382904910853 ()

  • Length: 29 Inch
  • Width: 33.5 Inch
  • Height: 33.5 Inch
491085

  • Cell morphology analyser IVD, manual
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon CRT
In Commercial Distribution

  • B22217 ()


  • Orthokeratology contact lens
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