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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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Earlens Processor - 00850013007462

Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IPR02XX
Not in Commercial Distribution

  • 00850013007462 ()
IPR02XX

  • Tympanic membrane contact hearing aid sound processor

Earlens Processor - 00850013007202

Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
IPR01XX
Not in Commercial Distribution

  • 00850013007202 ()
IPR01XX

  • Tympanic membrane contact hearing aid sound processor

Earlens Processor - 00850013007011

Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
PREL1XX
Not in Commercial Distribution

  • 00850013007011 ()
PREL1XX

  • Tympanic membrane contact hearing aid sound processor

LenSx® SoftFit™ - 00380659982767

LenSx® SoftFit™ Patient Interface Flat
Alcon Laboratories, Inc.
8065998276
In Commercial Distribution

  • 00380659982767 ()
  • 20380659982761 ()


  • Ophthalmic laser system eyeball positioning suction cup

LenSx® SoftFit™ - 00380659982750

LenSx® SoftFit™ Patient Interface Steep
Alcon Laboratories, Inc.
8065998275
In Commercial Distribution

  • 00380659982750 ()
  • 20380659982754 ()


  • Ophthalmic laser system eyeball positioning suction cup

LenSx® SoftFit™ - 00380659982743

LenSx® SoftFit™ Patient Interface Nominal
Alcon Laboratories, Inc.
8065998274
In Commercial Distribution

  • 00380659982743 ()
  • 20380659982747 ()


  • Ophthalmic laser system eyeball positioning suction cup

LenSx® - 00380659981630

LenSx® Laser Patient Interface
Alcon Laboratories, Inc.
8065998163
In Commercial Distribution

  • 10380659981637 ()
  • 00380659981630 ()


  • Ophthalmic laser system eyeball positioning suction cup

LENSX - 00380650000576

LENSXPATIENT INTERFACE FLAP 10PK,EO
Alcon Laboratories, Inc.
8065000057
In Commercial Distribution

  • 10380650000573 ()
  • 00380650000576 ()


  • Ophthalmic laser system eyeball positioning suction cup

LENSX - 00380650000569

LENSX SOFTFIT PATIENT INTERFACEI FLAT,EO
Alcon Laboratories, Inc.
8065000056
In Commercial Distribution

  • 20380650000563 ()
  • 00380650000569 ()


  • Ophthalmic laser system eyeball positioning suction cup

LENSX - 00380650000552

LENSX SOFTFIT PATIENT INTERFACE STEEP,EO
Alcon Laboratories, Inc.
8065000055
In Commercial Distribution

  • 20380650000556 ()
  • 00380650000552 ()


  • Ophthalmic laser system eyeball positioning suction cup

LENSX - 00380650000545

LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
Alcon Laboratories, Inc.
8065000054
In Commercial Distribution

  • 20380650000549 ()
  • 00380650000545 ()


  • Ophthalmic laser system eyeball positioning suction cup

LenSx, Alcon - 10380659982252

LENSX LASER SOFTFIT PATIENT
Alcon Laboratories, Inc.
8065998225
In Commercial Distribution

  • 10380659982252 ()
  • 20380659982259 ()
  • 00380659982255 ()


  • Ophthalmic laser system eyeball positioning suction cup

LENSX - 10380650000535

LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO
Alcon Laboratories, Inc.
8065000053
In Commercial Distribution

  • 10380650000535 ()
  • 00380650000538 ()
  • 20380650000532 ()


  • Ophthalmic laser system eyeball positioning suction cup

MeniconZ (tisilfocon A) Clear - 00884465092011

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

MeniconZ (tisilfocon A) Blue - 00884465091014

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 - B22207

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 - B22205

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

Paraperm EW - B22203

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

Fluoroperm 92 - B22204

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

Custom Stable - 00860011844136

Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material
Valley Contax, Inc.
Optimum Extreme (roflufocon E) Clear
In Commercial Distribution

  • 00860011844136 ()


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

Custom Stable - 00860011844129

Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Light Blue material
Valley Contax, Inc.
Optimum Extreme (roflufocon E) Light Blue
In Commercial Distribution

  • 00860011844129 ()


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

Custom Stable - 00860011844112

Rigid Gas Permeable Scleral Contact Lens for Daily Wear
Valley Contax, Inc.
Optimum Exra (roflufocon D) Clear
In Commercial Distribution

  • 00860011844112 ()


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

Custom Stable - 00860011844105

Rigid Gas Permeable Scleral Contact Lens for Daily Wear
Valley Contax, Inc.
Optimum Exra (roflufocon D) Light Blue
In Commercial Distribution

  • 00860011844105 ()


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

Loox - 00696792090222

No Description
Camden Passage Inc
09.022
In Commercial Distribution

  • 00696792090222 ()


  • Soft corrective contact lens, daily-wear

Loox - 00696792090208

No Description
Camden Passage Inc
09.020
In Commercial Distribution

  • 00696792090208 ()


  • Soft corrective contact lens, daily-wear

OP-6 - 00858174006560

OP-6 Fluoro-silicone Acrylate daily wear contact lens
LAGADO CORPORATION, THE
560
In Commercial Distribution

  • 00858174006560 ()


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

OP-3 - 00858174006539

OP-3 Fluoro-silicone Acrylate daily wear contact lens
LAGADO CORPORATION, THE
539
In Commercial Distribution

  • 00858174006539 ()


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

OP-2 - 00858174006522

OP-2 Fluoro-silicone Acrylate daily wear contact lens
LAGADO CORPORATION, THE
522
In Commercial Distribution

  • 00858174006522 ()


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

TYRO-97 - 00858174006058

TYRO-97 Fluoro-silicone acrylate daily wear contact lens
LAGADO CORPORATION, THE
058
In Commercial Distribution

  • 00858174006058 ()


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

ONSI-56 - 00858174006041

ONSI-56 Fluoro-silicone acrylate daily wear contact lens
LAGADO CORPORATION, THE
041
In Commercial Distribution

  • 00858174006041 ()


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

FLOSI - 00858174006034

FLOSI Fuoro-silicone Acrylat daily wear contact lens
LAGADO CORPORATION, THE
034
In Commercial Distribution

  • 00858174006034 ()


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

SA-32 - 00858174006027

SA-32 Fluoro-silicone Acrylate daily wear contact lens
LAGADO CORPORATION, THE
027
In Commercial Distribution

  • 00858174006027 ()


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

SA-18 - 00858174006010

SA-18 Silicone Acrylate daily wear contact lens
LAGADO CORPORATION, THE
010
In Commercial Distribution

  • 00858174006010 ()


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

Acuity - 00850203008330

Rigid-gas-permeable contact lens - daily wear tisilfocon A
ACUITY POLYMERS, INC.
181
In Commercial Distribution

  • 00850203008330 ()


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

Acuity - 00850203008040

Rigid-gas-permeable contact lens - daily wear fluoroxyfocon A
ACUITY POLYMERS, INC.
200
In Commercial Distribution

  • 00850203008040 ()


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

Acuity - 00850203008033

Rigid-gas-permeable contact lens - daily wear oprifocon A
ACUITY POLYMERS, INC.
85
In Commercial Distribution

  • 00850203008033 ()


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

Acuity - 00850203008026

Rigid-gas-permeable contact lens - daily wear enflufocon B
ACUITY POLYMERS, INC.
58
In Commercial Distribution

  • 00850203008026 ()


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

Acuity - 00850203008019

Rigid-gas-permeable contact lens - daily wear enflufocon A
ACUITY POLYMERS, INC.
18
In Commercial Distribution

  • 00850203008019 ()


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

Acuity - 00850203008002

Rigid-gas-permeable contact lens - daily wear hexafocon A
ACUITY POLYMERS, INC.
100
In Commercial Distribution

  • 00850203008002 ()


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

1-Day Flat Pack Trial9 BC840 - 00884465659771

No Description
MENICON CO.,LTD.
-13.00
In Commercial Distribution

  • 00884465659771 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659764

No Description
MENICON CO.,LTD.
-12.75
In Commercial Distribution

  • 00884465659764 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659757

No Description
MENICON CO.,LTD.
-12.50
In Commercial Distribution

  • 00884465659757 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659740

No Description
MENICON CO.,LTD.
-12.25
In Commercial Distribution

  • 00884465659740 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659733

No Description
MENICON CO.,LTD.
-12.00
In Commercial Distribution

  • 00884465659733 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659726

No Description
MENICON CO.,LTD.
-11.75
In Commercial Distribution

  • 00884465659726 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659719

No Description
MENICON CO.,LTD.
-11.50
In Commercial Distribution

  • 00884465659719 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659702

No Description
MENICON CO.,LTD.
-11.25
In Commercial Distribution

  • 00884465659702 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659696

No Description
MENICON CO.,LTD.
-11.00
In Commercial Distribution

  • 00884465659696 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659689

No Description
MENICON CO.,LTD.
-10.75
In Commercial Distribution

  • 00884465659689 ()


  • Soft corrective contact lens, daily-disposable

1-Day Flat Pack Trial9 BC840 - 00884465659672

No Description
MENICON CO.,LTD.
-10.50
In Commercial Distribution

  • 00884465659672 ()


  • Soft corrective contact lens, daily-disposable
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