FDA.reportPublic FDA data

Suturable vitrectomy lens ring 1284.DW till 1284.IW

Primary DI
08717872004525
Brand
Suturable vitrectomy lens ring 1284.DW till 1284.IW
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1284.R
Catalog number
1284.R
Published
2016-09-23
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
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033950000DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)2004-02-20HJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872004525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872004525087178720045258717872004525

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
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