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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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FSA 38 - B22211

FSA 38 (paflufocon E) 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, posterior or bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve 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 FSA 38 (paflufocon E) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer.
Paragon Vision Sciences, Inc.
FSA 38
In Commercial Distribution

  • B22211 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear

Fluoroperm 30 - B22206

FluoroPerm® 30 (paflufocon 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. 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® 30 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 30 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 30
In Commercial Distribution

  • B22206 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear

Optacryl 60 - B22201

Optacryl® 60 (kolfocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut firm contact lenses with spherical anterior and posterior surfaces. 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 Optacryl® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The lens material is available in blue, green, or gray versions. The blue lens contains Microlith Blue 4 G-K; the green lens contains Sunfast Green No. 7; and, the gray lens contains D&C Green No. 6, D&C Violet No. 2, and Perox Yellow No. 9 as the color additives.
Paragon Vision Sciences, Inc.
Optacryl 60
In Commercial Distribution

  • B222010 ()
  • B22201 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear

Ocylens - 00811059035031

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059035031 ()
  • 10811059035038 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059035024

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059035024 ()
  • 10811059035021 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059035017

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059035017 ()
  • 10811059035014 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059035000

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059035000 ()
  • 10811059035007 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034997

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034997 ()
  • 10811059034994 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034782

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034782 ()
  • 10811059034789 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034775

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034775 ()
  • 10811059034772 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034768

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034768 ()
  • 10811059034765 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034751

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034751 ()
  • 10811059034758 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034744

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034744 ()
  • 10811059034741 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034737

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034737 ()
  • 10811059034734 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034720

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034720 ()
  • 10811059034727 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034713

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034713 ()
  • 10811059034710 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034706

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034706 ()
  • 10811059034703 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034690

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034690 ()
  • 10811059034697 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034683

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034683 ()
  • 10811059034680 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034676

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034676 ()
  • 10811059034673 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034669

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034669 ()
  • 10811059034666 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034652

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034652 ()
  • 10811059034659 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034645

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034645 ()
  • 10811059034642 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034638

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034638 ()
  • 10811059034635 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034621

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034621 ()
  • 10811059034628 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034614

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034614 ()
  • 10811059034611 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034607

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034607 ()
  • 10811059034604 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034591

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034591 ()
  • 10811059034598 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034584

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034584 ()
  • 10811059034581 ()


  • Soft corrective contact lens, daily-disposable

Ocylens - 00811059034577

1-Day Ocylens (etafilcon A) Daily Disposable Soft Contact Lenses
WESTERN BIOTECH LLC
01
In Commercial Distribution

  • 00811059034577 ()
  • 10811059034574 ()


  • Soft corrective contact lens, daily-disposable
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