FDA.reportPublic FDA data

Disposable Infusion Cannula, 6.0 mm, for silicone oil

Primary DI
18717872002283
Brand
Disposable Infusion Cannula, 6.0 mm, for silicone oil
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1272.BSD
Catalog number
1272.BSD
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
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872002286PrimaryGS10
18717872002283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872002286087178720022868717872002286
1871787200228318717872002283

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407522184
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08058340220710Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08058340220727Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08058340220734Passive Reservoir AKTIVE SRLKYG2024-01-11
08058340220741Active ReservoirAKTIVE SRLKYG2024-01-11
08056477557518Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11
08056477559598Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2023-12-19
08058340220994Dual Bore Cannula 20GAKTIVE SRLKYG2023-12-19
08058340221007Dual Bore Cannula 23GAKTIVE SRLKYG2023-12-19
08058340221014Dual Bore Cannula 25GAKTIVE SRLKYG2023-12-19
08056477559604Dual Bore Cannula 25G, 36mmAKTIVE SRLKYG2023-12-19