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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
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.GW
In Commercial Distribution

  • 08717872004396 ()
1284.GW

  • Therapeutic contact lens
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.EW
In Commercial Distribution

  • 08717872004341 ()
1284.EW

  • Therapeutic contact lens
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.DW
In Commercial Distribution

  • 08717872004303 ()
1284.DW

  • Therapeutic contact lens
Kit containing 850007135072(Emerald Toric, opirfocon A, Blue) and 850007135089(Emerald Toric, oprifocon A, Green)
Euclid Vision Corporation
Emerald Toric
Not in Commercial Distribution

  • 85000713500232 ()
  • 85000713599960 ()


  • Orthokeratology contact lens
Kit containing 850007135058 (Emerald Toric, oprifocon A, Blue) and 850007135065 (Emerald Toric, oprifocon A, Green)
Euclid Vision Corporation
Emerald Toric
Not in Commercial Distribution

  • 85000713500225 ()
  • 85000713599977 ()


  • Orthokeratology contact lens
Kit containing 00850007135027 (Emerald, oprifocon A, Blue) and 00850007135034 (Emerald, oprifocon A, Green)
Euclid Vision Corporation
Emerald
Not in Commercial Distribution

  • 85000713500218 ()
  • 85000713599984 ()


  • Orthokeratology contact lens
Kit containing 850007135003 (Emerald, oprificon A, Blue) and 850007135010 (Emerald, oprifocon A, Green)
Euclid Vision Corporation
Emerald
Not in Commercial Distribution

  • 85000713500201 ()
  • 85000713599991 ()


  • Orthokeratology contact lens
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). 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”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon CRT Dual Axis® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is a 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, red, yellow, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 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 Dual Axis
In Commercial Distribution

  • B22219 ()


  • Orthokeratology contact lens
Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). 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”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon CRT® 100 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, red, yellow, and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 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 100
In Commercial Distribution

  • B22218 ()


  • Orthokeratology contact lens
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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