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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Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
LIFESTYLE CO INC, THE
MS0610/H
Not in Commercial Distribution

  • 00830002000056 ()


  • Contact lens agitation cleaning system, mechanical
PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 100MM RECORDING DEPTH,
PMT CORPORATION
2102-16-192
In Commercial Distribution

  • 00650551004837 ()


  • Depth electrode
PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 90MM RECORDING DEPTH,
PMT CORPORATION
2102-16-191
In Commercial Distribution

  • 00650551004820 ()


  • Depth electrode
PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, 0.8MM OD, 2MM CONTACT LENGTH, 80MM RECORDING DEPTH,
PMT CORPORATION
2102-16-190
In Commercial Distribution

  • 00650551004813 ()


  • Depth electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 2MM 64 CONTACT, 8X8, CONTACT, RADIOPAQUE, SMOOTH, INLINE, CONTACTS NUMBERED, NON-STERILE
PMT CORPORATION
2110-64-158-NS
In Commercial Distribution

  • 00650551004073 ()


  • Cortical electrode
SEEG, 16 CONTACT, 2MM & 0.5MM CONTACT DIA., 5MM SPACING AND 13MM BETWEEN CONTACT 9&10, 33MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-174
In Commercial Distribution

  • 00650551005506 ()


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

  • 10380650000573 ()
  • 00380650000576 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACEI FLAT,EO
Alcon Laboratories, Inc.
8065000056
In Commercial Distribution

  • 20380650000563 ()
  • 00380650000569 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACE STEEP,EO
Alcon Laboratories, Inc.
8065000055
In Commercial Distribution

  • 20380650000556 ()
  • 00380650000552 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
Alcon Laboratories, Inc.
8065000054
In Commercial Distribution

  • 20380650000549 ()
  • 00380650000545 ()


  • Ophthalmic laser system eyeball positioning suction cup
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
No Description
EARLENS CORPORATION
IPR01CH
In Commercial Distribution

  • 00850013007516 ()
IPR01CH

  • Tympanic membrane contact hearing aid sound processor
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
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
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™ Patient Interface Flat
Alcon Laboratories, Inc.
8065998276
In Commercial Distribution

  • 00380659982767 ()
  • 20380659982761 ()


  • Ophthalmic laser system eyeball positioning suction cup
LenSx® SoftFit™ Patient Interface Steep
Alcon Laboratories, Inc.
8065998275
In Commercial Distribution

  • 00380659982750 ()
  • 20380659982754 ()


  • Ophthalmic laser system eyeball positioning suction cup
LenSx® SoftFit™ Patient Interface Nominal
Alcon Laboratories, Inc.
8065998274
In Commercial Distribution

  • 00380659982743 ()
  • 20380659982747 ()


  • Ophthalmic laser system eyeball positioning suction cup
LenSx® Laser Patient Interface
Alcon Laboratories, Inc.
8065998163
In Commercial Distribution

  • 10380659981637 ()
  • 00380659981630 ()


  • Ophthalmic laser system eyeball positioning suction cup
Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR-Brown. This is for quantity of 2.
EARLENS CORPORATION
PREL1XX2
Not in Commercial Distribution

  • 08500130070024 ()
  • 08500130070154 ()
PREL1XX2

  • Tympanic membrane contact hearing aid sound processor
LENSX LASER SOFTFIT PATIENT
Alcon Laboratories, Inc.
8065998225
In Commercial Distribution

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


  • Ophthalmic laser system eyeball positioning suction cup
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
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
InterGuard 4.0mm 10pk
ULTRADENT PRODUCTS, INC.
4016
In Commercial Distribution

  • 00883205019943 ()
4016

  • Tooth separator
InterGuard 5.5mm 10pk
ULTRADENT PRODUCTS, INC.
4017
In Commercial Distribution

  • 00883205019783 ()
4017

  • Tooth separator
InterGuard 5.5mm 50pk
ULTRADENT PRODUCTS, INC.
4012
In Commercial Distribution

  • 00883205019295 ()
4012

  • Tooth separator
InterGuard Kit
ULTRADENT PRODUCTS, INC.
3097
In Commercial Distribution

  • 00883205015884 ()
3097

  • Tooth separator
InterGuard 4.0mm 50pk
ULTRADENT PRODUCTS, INC.
4011
In Commercial Distribution

  • 00883205015631 ()
4011

  • Tooth separator
Radiopaque Seps Anterior White Loose Separators 1000/pk
ORTHO TECHNOLOGY, INC.
480-305
In Commercial Distribution

  • 00190730006974 ()


  • Tooth separator
Radiopaque Sep Posterior White Loose Separators 1000/pk
ORTHO TECHNOLOGY, INC.
480-304
In Commercial Distribution

  • 00190730006967 ()


  • Tooth separator
Radiopaque Seps Posterior Blue Loose Separators 1000/pk
ORTHO TECHNOLOGY, INC.
480-302
In Commercial Distribution

  • 00190730006950 ()


  • Tooth separator
Radiopaque Separators Molded 1000/pk
ORTHO TECHNOLOGY, INC.
480-306
In Commercial Distribution

  • 00190730032669 ()


  • Tooth separator
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
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
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