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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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Deluxe Kit - 00192538901024

No Description
MENICON CO.,LTD.
MEN00308
In Commercial Distribution

  • 00192538901024 ()


  • Contact lens care kit

Deluxe Scleral Lens Kit - 00192538901017

No Description
MENICON CO.,LTD.
MEN00321
In Commercial Distribution

  • 00192538901017 ()


  • Contact lens care kit

Symons OCT Image Enhancing Lens 17mm O.D. - 00630238123495

No Description
OCULAR INSTRUMENTS, INC.
OSIE-17
In Commercial Distribution

  • 00630238123495 ()
  • 00630238123518 ()


  • Laser lens, ophthalmic, surgical

Symons OCT Image Enhancing Lens 20mm O.D. - 00630238123297

No Description
OCULAR INSTRUMENTS, INC.
OSIE-20
In Commercial Distribution

  • 00630238123297 ()
  • 00630238123310 ()


  • Laser lens, ophthalmic, surgical

Mainster Wide Filed EX - 00630238123020

No Description
OCULAR INSTRUMENTS, INC.
OMRA-WFEX
In Commercial Distribution

  • 00630238123310 ()
  • 00630238123020 ()


  • Vitrectomy contact lens, reusable

13063 RxSight 0.766x Mag Contact Lens - 00630238122245

No Description
OCULAR INSTRUMENTS, INC.
13063
In Commercial Distribution

  • 00630238122245 ()
  • 00630238122269 ()


  • Laser lens, ophthalmic, surgical

MaxAC® Capsulotomy Laser Lens - 00630238121156

No Description
OCULAR INSTRUMENTS, INC.
OAYAAC
In Commercial Distribution

  • 00630238121156 ()
  • 00630238121217 ()


  • Laser lens, ophthalmic, surgical

1.0mm Fundus Laser Lens - 00630238121002

No Description
OCULAR INSTRUMENTS, INC.
OFA1.0
In Commercial Distribution

  • 00630238121002 ()
  • 00630238056670 ()


  • Laser lens, ophthalmic, surgical

Vitreolysis Two Lens Set - 00630238118606

No Description
OCULAR INSTRUMENTS, INC.
OJK-2S
In Commercial Distribution

  • 00630238118606 ()
  • 00630238088381 ()


  • Laser lens, ophthalmic, surgical

Navilas Rapid PRP - 00630238110679

No Description
OCULAR INSTRUMENTS, INC.
ONPRP
In Commercial Distribution

  • 00630238110679 ()
  • 00630238110686 ()


  • Laser lens, ophthalmic, surgical

Karickhoff 30mm Off-Axis Vitreous Laser Lens - 00630238109703

No Description
OCULAR INSTRUMENTS, INC.
OJKPY-30
In Commercial Distribution

  • 00630238109703 ()
  • 00630238109727 ()


  • Laser lens, ophthalmic, surgical

2.0mm Fundus Laser Lens - 00630238107679

No Description
OCULAR INSTRUMENTS, INC.
OFA2.0
In Commercial Distribution

  • 00630238107679 ()
  • 00630238077026 ()


  • Laser lens, ophthalmic, surgical

RxSight .835x Fundus Lens - 00630238102636

No Description
OCULAR INSTRUMENTS, INC.
OCVF
In Commercial Distribution

  • 00630238102636 ()
  • 00630238118873 ()


  • Laser lens, ophthalmic, surgical

Khaw Surgical Gonioprism - 00630238084802

No Description
OCULAR INSTRUMENTS, INC.
OKSG
In Commercial Distribution

  • 00630238084802 ()
  • 00630238084833 ()


  • Gonioscope

Staurenghi 230 SLO Retina Lens - 00630238076135

No Description
OCULAR INSTRUMENTS, INC.
OSR230
In Commercial Distribution

  • 00630238076135 ()
  • 00630238109062 ()


  • Laser lens, ophthalmic, surgical

Mommy Matters - 00850047439147

NeoHeat
Joylux, Inc.
MM-9000
In Commercial Distribution

  • 00850047439147 ()


  • Perineal warmer

SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT® - 00852475007042

1 Each SUPER VIEW® Sterile Disposable HD Plus Lens Set for use with ZEISS RESIGHT®
OCULUS SURGICAL INC
40240
In Commercial Distribution

  • 00852475007059 ()
  • 00852475007042 ()
40240

  • Ophthalmic diagnostic condensing lens

SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT® - 00856222004063

1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)
INSIGHT INSTRUMENTS, INC.
TS-ZR-LS
In Commercial Distribution

  • 10856222004060 ()
  • 00856222004063 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
40226

  • Ophthalmic diagnostic condensing lens
  • Vitrectomy contact lens, single-use

SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe - 00856222004032

SUPER VIEW® Hassan-Tornambe Disposable Contact Lens for use during vitreo-retinal surgery
OCULUS SURGICAL INC
40417
In Commercial Distribution

  • 10856222004039 ()
  • 00856222004032 ()

  • Outer Diameter: 13 Millimeter
40417

  • Vitrectomy contact lens, single-use

SUPER VIEW® Disposable Lens Set - 00856222004001

SUPER VIEW® Sterile Lens Pack for use with the SUPER VIEW® System and the BIOM®
OCULUS SURGICAL INC
40411
In Commercial Distribution

  • 00856222004001 ()
  • 10856222004008 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
  • Outer Diameter: 42 Millimeter
40411

  • Ophthalmic diagnostic condensing lens
  • Vitrectomy contact lens, single-use

SUPER VIEW Lens, Disposable Contact, Tornambe - 00856222004209

SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
OCULUS SURGICAL INC
40413
In Commercial Distribution

  • 10856222004206 ()
  • 00856222004209 ()

  • Outer Diameter: 13 Millimeter
40413

  • Vitrectomy contact lens, single-use

SUPER VIEW® Disposable Lens Set, Pivot Plus - 00856222004179

1 Each SUPER VIEW® Sterile Disposable Pivot Plus Lens Set for use with the SUPER VIEW® System or BIOM®
OCULUS SURGICAL INC
40227
In Commercial Distribution

  • 10856222004176 ()
  • 00856222004179 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
  • Outer Diameter: 42 Millimeter
40227

  • Vitrectomy contact lens, single-use
  • Ophthalmic diagnostic condensing lens

SUPER VIEW® Disposable Lens Set for RESIGHT® - 00856222004049

1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens
INSIGHT INSTRUMENTS, INC.
40219
In Commercial Distribution

  • 10856222004046 ()
  • 00856222004049 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
40219

  • Vitrectomy contact lens, single-use
  • Ophthalmic diagnostic condensing lens

Hayden Medical - 00840319716632

Large Synthetic Latex Free Rubber Suction Cups, autoclavable, one dozen
Hayden Medical, Inc.
OP23-012
In Commercial Distribution

  • 00840319716632 ()
OP23-012

  • Corneal shield applicator

Disposable Vitrectomy Lens: 30° Prism - 08717872004440

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.ID
In Commercial Distribution

  • 08717872004440 ()
  • 18717872004447 ()
1284.ID

  • Vitrectomy contact lens, single-use

Disposable Vitrectomy Lens: Wide View - 08717872004389

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.GD
In Commercial Distribution

  • 08717872004389 ()
  • 18717872004386 ()
1284.GD

  • Vitrectomy contact lens, single-use

Disposable Vitrectomy Lens: Magnifying - 08717872004365

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.FD
In Commercial Distribution

  • 08717872004365 ()
  • 18717872004362 ()
1284.FD

  • Vitrectomy contact lens, single-use

Disposable Vitrectomy Lens: Biconcave - 08717872004327

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.ED
In Commercial Distribution

  • 08717872004327 ()
  • 18717872004324 ()
1284.ED

  • Vitrectomy contact lens, single-use

Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD. - 08717872004280

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.DIS
In Commercial Distribution

  • 08717872004280 ()
  • 18717872004287 ()
1284.DIS

  • Vitrectomy contact lens, single-use

Disposable Vitrectomy Lens: Flat - 08717872004266

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1284.DD
In Commercial Distribution

  • 08717872004266 ()
  • 18717872004263 ()
1284.DD

  • Vitrectomy contact lens, single-use

DMV Classic - 00080875975955

Contact lens remover/inserter with suction bulb for hard and gp contact lenses
DMV CORPORATION
595
In Commercial Distribution

  • 00080875975955 ()
  • 00080875975962 ()
  • 10080875975952 ()


  • Rigid contact lens inserter/remover

DMV 45 - 00080875975856

CL remover/inserter for hard and gp CL with 45° tilted suction cup
DMV CORPORATION
585
In Commercial Distribution

  • 00080875975863 ()
  • 00080875975856 ()
585

  • Rigid contact lens inserter/remover

DMV MiniCup - 00080875975290

Contact lens remover/inserter with a smaller and deeper cup for small hard and gp contact lenses.
DMV CORPORATION
529
In Commercial Distribution

  • 00080875975290 ()
529

  • Rigid contact lens inserter/remover

DMV Magic Touch - 00080875975153

Contact lens remover/inserter with small air channel for hard and gp contact lenses. Suction is optional
DMV CORPORATION
515
In Commercial Distribution

  • 00080875975160 ()
  • 00080875975153 ()
515

  • Rigid contact lens inserter/remover

DMV Luma Serter Plus - 00080875974248

45 degree Inserter for large contact lenses to be used with a pen light. No suction
DMV CORPORATION
424
In Commercial Distribution

  • 00080875974248 ()
424

  • Rigid contact lens inserter/remover

DMV Luma Serter - 00080875974231

Inserter for contact lenses to be used with pen light. No suction
DMV CORPORATION
423
In Commercial Distribution

  • 00080875974231 ()


  • Rigid contact lens inserter/remover

DMV Vented Scleral Cup - 00080875971100

Contact lens Inserter with air channel for inserting hybrid, large soft and gp contact lenses. No suction
DMV CORPORATION
110
In Commercial Distribution

  • 00080875971100 ()
  • 10080875971107 ()
110

  • Rigid contact lens inserter/remover

DMV Scleral Cup - 00080875971094

Contact lens remover/inserter with suction bulb for scleral contact lenses and handling prosthetic eyes
DMV CORPORATION
109
In Commercial Distribution

  • 00080875971094 ()
  • 10080875971091 ()
  • 00080875971131 ()
109

  • Rigid contact lens inserter/remover

Vitrectomy contact lens, single-use - 03760087123708

A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA AUTOSTABLE VITRECTOMY LENS, FLAT
In Commercial Distribution

  • 53760087123703 ()
  • 03760087123708 ()

  • Outer Diameter: 13 Millimeter
S5.8050U

  • Vitrectomy contact lens, single-use

Vitrectomy contact lens, single-use - 03760087123692

A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA BICONCAVE LENS
In Commercial Distribution

  • 53760087123697 ()
  • 03760087123692 ()

  • Outer Diameter: 11.25 Millimeter
S5.8040U

  • Vitrectomy contact lens, single-use
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