FDA.reportPublic FDA data

Reusable Two step cannula system.(23 gauge / 0.6 mm)

Primary DI
08717872002408
Brand
Reusable Two step cannula system.(23 gauge / 0.6 mm)
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1272.E06
Catalog number
1272.E06
Published
2021-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08717872002408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872002408087178720024088717872002408

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, reusableA collection of non-powered devices intended to be used to create a channel through the sclera for posterior segment ophthalmic surgery. 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). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407522184
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717872001401Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max.1267.NMD051267.NMD052016-09-30
08717872001425Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max.1267.NMD251267.NMD252016-09-30
08717872003085Infusion cannula forceps127612762020-11-16
08717872003115Scleral plug forceps127712772020-11-16
08717872003375Charles Flute instrument.128112812020-11-16
08717872004280Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.1284.DIS1284.DIS2016-09-23
08717872008578Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.2267.NMD062267.NMD062016-09-30
08717872016771Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max2267.NMD042267.NMD042016-09-23
08717872017297Disposable Pneumatic Vitrectome, 25 Gauge/0.5 mm working with 37 PSI, max2500 c 2267.NMD052267.NMD052016-09-23
08717872021416Cryo Probe: Extended Retinal, 2.5mm1540.D1540.D2017-07-12
0871787203710325G Extendible subretinal injection cannula (41G)1270.EXT251270.EXT252025-09-26
0871787203711027G Extendible subretinal injection cannula (41G)1270.EXT271270.EXT272025-09-26
18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)3269.E06-002025-04-01
18717872035540TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)3269.EB05-002025-04-01
1871787203654727G Two Dimensional Cutter – 20k CPM9268.VIT27-002025-04-01
08717872034720EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.402-002025-03-31
18717872035397Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.43269.D04-002025-03-31
18717872035403Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 3269.D-002025-03-31
18717872035410TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga3269.B04-003269.B04-002025-03-31
1871787203542723 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor3269.SBS06-00 2025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20380650004684UNITYAlcon Laboratories, Inc.NGY2024-11-19
20380650004707AlconAlcon Laboratories, Inc.NGY2024-11-19
10380650003529ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003536ALCONAlcon Laboratories, Inc.NGY2024-07-02
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
1871787203495627G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203485723G Two Step Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203486423G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203487125G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203488827G Single TrocarD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203489523G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203490125G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
1871787203491827G Cannula set with High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-20
10803878053058Aurotrocar AUROLABNGY2023-06-27
08052276015334Trocar 29G with removable valveAKTIVE SRLNGY2023-06-12
08052276015327Trocar 27G with removable valve AKTIVE SRLNGY2023-06-12
08056477557938Trocar set 27g with removable valve AKTIVE SRLNGY2023-06-12
08052276015358Trocar 20g with removable valveAKTIVE SRLNGY2023-06-12
08056477558515Trocar 23G with removable valveAKTIVE SRLNGY2023-06-12
08056477557143Trocar 25G with removable valveAKTIVE SRLNGY2023-06-12