FDA.reportPublic FDA data

27G High Flow infusion line

Primary DI
08717872034959
Brand
27G High Flow infusion line
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1279.HF27-00
Catalog number
1279.HF27-00
Published
2024-02-21
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
NGYCannula, Trocar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGYCannula, Trocar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872034959PrimaryGS10
18717872034956Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872034959087178720349598717872034959
1871787203495618717872034956

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.

Regulatory Flags#

DUNS number
407522184
Device count
6
Premarket exempt
true
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
00380650003492ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003508ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003553ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003560ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003584ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003591ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003959UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650003966UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650004673ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003499ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003505ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003550ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003567ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003581ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003598ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003956UNITYAlcon Laboratories, Inc.NGY2025-04-08
10380650003963UNITYAlcon Laboratories, Inc.NGY2025-04-08
20380650004677ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650004680UNITYAlcon Laboratories, Inc.NGY2024-11-19
00380650004703AlconAlcon Laboratories, Inc.NGY2024-11-19
20380650004684UNITYAlcon Laboratories, Inc.NGY2024-11-19
20380650004707AlconAlcon Laboratories, Inc.NGY2024-11-19
00380650003522ALCONAlcon Laboratories, Inc.NGY2024-07-02
00380650003539ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003529ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003536ALCONAlcon Laboratories, Inc.NGY2024-07-02
0871787203493523G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
0871787203494225G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203493223G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203494925G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21