FDA.reportPublic FDA data

EVA Vitrectomy Pack VGPC Input 20G

Primary DI
08717872034652
Brand
EVA Vitrectomy Pack VGPC Input 20G
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
8300.20G12-00
Catalog number
8300.20G12-00
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190875000EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International)2019-09-25HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872034652PrimaryGS10
18717872034659Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872034652087178720346528717872034652
1871787203465918717872034659

Regulatory Flags#

DUNS number
407522184
Device count
6
Lot or batch
true
Expiration date on label
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
00812480011137Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011151Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011168Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011175Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011182Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480013049NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011083Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011090Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011144Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00380657530274LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530281LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530298LEGION, INTREPIDAlcon Laboratories, Inc.HQC2026-07-22
00380657530373LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530502LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530564LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657530755LEGIONAlcon Laboratories, Inc.HQC2026-07-22
00380657531639LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531646LEGION, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531653LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00380657531660LEGION, INTREPID, KELMANAlcon Laboratories, Inc.HQC2026-07-22
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQF2025-06-24
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