FDA.reportPublic FDA data

Landers Wide Field Temporary Keratoprosthesis 8.2mm

Primary DI
00630238006897
Brand
Landers Wide Field Temporary Keratoprosthesis 8.2mm
Company
OCULAR INSTRUMENTS, INC.
Model
OLTK 8.2
Published
2016-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MLPKeratoprosthesis, Temporary Implant, Surgical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLPKeratoprosthesis, Temporary Implant, Surgical UseOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910828000LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESISOcular Instruments, Inc.1991-08-21MLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630238006897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630238006897006302380068976302380068970630238006897

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, reusableA non-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 reusable device that must be sterilized before application.

Sterilization Methods#

Method table
Method
"[""Peracetic Acid"", ""Ethylene Oxide""]"
Peracetic Acid;Ethylene Oxide

Regulatory Flags#

DUNS number
046212387
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630238009973Landers Lens ForcepsOLV-FCP2019-06-12
00630238056656Handle For Vitrectomy LensesOLIV-H2019-06-12
00630238084741MaxAC® Lens StandOI-LSA2019-06-11
00630238095235MaxField® 100D Slit Lamp Indirect Lens (Green)OI-100M/GN2019-06-10
00630238081795MaxLight® Standard 90D Slit Lamp Indirect Lens (Green)OI-STD/GN2019-06-11
00630238049023Ultra View Small Pupil Slit Lamp Binocular Indirect LensOI-SP2019-06-11
00630238077422MaxAC® 20D Binocular Indirect LensOI-20A2019-06-11
00630238077491MaxAC® 28D Binocular Indirect LensOI-28A2019-06-11
00630238081658MaxField® Standard 90D Slit Lamp Indirect Lens (Red)OI-STDM/R2019-06-11
00630238082082MaxLight® Standard 90D Slit Lamp Indirect Lens (Red)OI-STD/R2019-06-11
00630238082983MaxLight® High Mag 78D Slit Lamp Indirect Lens (Purple)OI-HM/P2019-06-11
00630238083058MaxLight® High Mag 78D Slit Lamp Indirect Lens (Gold)OI-HM/GD2019-06-11
00630238083331MaxField® Standard 90D Slit Lamp Indirect Lens w/Large Ring (Purple)OI-STDM-LR/P2019-06-11
00630238085113MaxField® High Mag 78 Slit Lamp Indirect Lens (Purple)OI-HM-78M/P2019-06-11
00630238085144MaxField® High Mag 78 Slit Lamp Indirect Lens (Red)OI-HM-78M/R2019-06-11
00630238092647MaxField® 22D Binocular Indirect Lens (Blue)OI-22M/B2019-06-11
00630238096959Saxena Retinal Grid 520OI-SRG5202019-06-11
00630238099073MaxLight® 18D Binocular Indirect Lens (Green)OI-18/GN2019-06-11
00630238099325MaxField® 18D Binocular Indirect Lens (Green)OI-18M/GN2019-06-11
00630238099332MaxField® 18D Binocular Indirect Lens (Purple)OI-18M/P2019-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630238006873Landers Wide Field Temporary Keratoprosthesis 6.2mm OCULAR INSTRUMENTS, INC.MLP2016-12-12
00630238006880Landers Wide Field Temporary Keratoprosthesis 7.2mm OCULAR INSTRUMENTS, INC.MLP2016-12-12
00630238113168Landers Wide Field Corneal WindowOCULAR INSTRUMENTS, INC.MLP2016-12-12
00630238008914Cobo 5.0mm Temporary KeratoprothesisOCULAR INSTRUMENTS, INC.MLP2016-12-09
00630238008921Cobo 6.5mm Temporary KeratoprothesisOCULAR INSTRUMENTS, INC.MLP2016-12-09
00630238008938Cobo 8.0mm Temporary KeratoprothesisOCULAR INSTRUMENTS, INC.MLP2016-12-09
08717872004532Eckardt temporary keratoprosthesis, Ø 7 mm, 2.8 mm depthD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MLP2016-09-23
08717872004549Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depthD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MLP2016-09-23
08717872004570Eckardt temporary keratoprosthesis, Ø 8 mm, 2.5 mm depthD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MLP2016-09-23