Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth

Primary DI
08717872004549
Brand
Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1285.2
Catalog number
1285.2
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
K902491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902491000ECKHARDT TEMPORARY KERATOPROSTHESISDutch Ophthalmic USA, Inc.1990-06-26MLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872004549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872004549087178720045498717872004549

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic contact lensA soft ophthalmic lens, typically made of a synthetic polymer/silicone, designed to be temporarily applied directly to the front surface of the eye (globe or cornea) to treat and manage non-refractive disorders such as cataract-removal wounds, corneal damage, and dry eyes. The device, sometimes referred to as a bandage contact lens, may be used to protect the eyes after surgery to allow wound healing; to treat corneal irregularities, erosions, and persistent epithelial defects/ulcers; to seal the anterior chamber; to deliver drugs; or for other treatment purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407522184
Device count
1
DM exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23G8523.4222021-06-11
08717872003221Universal silicone infusion line for 20 gauge/0.9 mm cannula system.1279.IA201279.IA202021-02-01
08717872003245Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP21279.P1279.P2021-02-01
08717872003993Disposable Backflush instrument, with extended silicone tip and active aspiratio1281.TDM1281.TDM2021-02-02
08717872004013Replacement backflush reservoir with active aspiration.1281.XD1281.XD2021-02-02
08717872004075MVR Blade 23-G, angled1282.D061282.D062021-02-09
08717872004099One step stiletto insertor.(23 gauge / 0.6 mm)1282.F061282.F062021-02-09
08717872007403Disposable keratoscope1420.D1420.D2023-09-14
08717872012339Crescent Knife, 2.25, 55°, bevel up51.111851.11182021-01-29
08717872012346Slit Knife, 2.2mm, angled 45°, bibevel51.372251.37222021-01-29
08717872012384MVR Blade 20G, straight51.523051.52302021-01-29
08717872015255Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo1279.IA20S1279.IA20S2021-02-01
08717872015712MVR Blade 20G, angled52.522052.52202021-01-29
08717872015736Trapezoid Knife 1.2 x 1.4mm, angled53.121453.12142021-01-29
08717872015743Slit Knife, 2.2mm, angled, bevel up53.372253.37222021-01-29
08717872015750Slit Knife, 2.75mm, angled, bevel up53.372753.37272021-01-29
08717872015798Clear Corneal Knife, 2.5mm, angled54.572554.57252021-01-29
08717872015934Stab Knife, 15°51.489151.48912021-01-29
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25G8525.4098525.4012021-06-11
08717872031828EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.4068525.4012021-06-11

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
00630238006897Landers Wide Field Temporary Keratoprosthesis 8.2mm 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
08717872004570Eckardt temporary keratoprosthesis, Ø 8 mm, 2.5 mm depthD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MLP2016-09-23