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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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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
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
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
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® 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
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
NeoHeat
Joylux, Inc.
MM-9000
In Commercial Distribution

  • 00850047439147 ()


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

  • 00840319716632 ()
OP23-012

  • Corneal shield applicator
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
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
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 PRISMATIC 35° LENS
In Commercial Distribution

  • 53760087123680 ()
  • 03760087123685 ()

  • Outer Diameter: 11.25 Millimeter
S5.8030U

  • Vitrectomy contact lens, single-use
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 VITRECTOMY LENS PLANOCONCAVE
In Commercial Distribution

  • 53760087123673 ()
  • 03760087123678 ()

  • Outer Diameter: 11.25 Millimeter
S5.8010U

  • Vitrectomy contact lens, single-use
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
S5.8000
In Commercial Distribution

  • 53760087122348 ()
  • 03760087122343 ()


  • Vitrectomy contact lens, single-use
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 PRISMATIC 30° LENS
In Commercial Distribution

  • 53760087122201 ()
  • 03760087122206 ()

  • Angle: 30 degree
S5.7030U

  • Vitrectomy contact lens, single-use
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