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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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Replacement cleaning chamber packaged in plastic zip-lock bag.
LIFESTYLE CO INC, THE
MS0610/H
Not in Commercial Distribution

  • 00830002000049 ()


  • Contact lens agitation cleaning system, mechanical
Replacement lens basket packaged in plastic zip-lock bag.
LIFESTYLE CO INC, THE
MS0610/H
Not in Commercial Distribution

  • 00830002000032 ()


  • Contact lens agitation cleaning system, mechanical
No Description
MENICON CO.,LTD.
Pale yellow
In Commercial Distribution

  • 00884465092011 ()


  • Rigid-gas-permeable corrective contact lens, extended-wear
  • Rigid-gas-permeable corrective contact lens, daily-wear
No Description
MENICON CO.,LTD.
Blue
In Commercial Distribution

  • 00884465091014 ()


  • Rigid-gas-permeable corrective contact lens, extended-wear
  • Rigid-gas-permeable corrective contact lens, daily-wear
FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses for daily wear and extended wear are available as lathe cut or molded firm contact lenses with spherical front and back surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 151 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 151 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 151
In Commercial Distribution

  • B22207 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 60
In Commercial Distribution

  • B22205 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric,bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm 92 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 92
In Commercial Distribution

  • B22204 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
Paraperm® EW (pasifocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. Paraperm® EW rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens.
Paragon Vision Sciences, Inc.
Paraperm EW
In Commercial Distribution

  • B22203 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
No Description
EARLENS CORPORATION
IPR01BL
In Commercial Distribution

  • 00850013007530 ()
IPR01BL

  • Tympanic membrane contact hearing aid sound processor
No Description
EARLENS CORPORATION
IPR01SI
In Commercial Distribution

  • 00850013007523 ()
IPR01SI

  • Tympanic membrane contact hearing aid sound processor
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