FDA.reportPublic FDA data

ULTRA FLOW

Primary DI
00380658173012
Brand
ULTRA FLOW
Company
Alcon Laboratories, Inc.
Model
00380658173012
Device description
ULTRAFLOW S/P 90 BENT TIP, .3 mm
Published
2018-03-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQCUnit, phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112425000INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECEAlcon Manufacturing, Ltd.2011-11-21HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380658173012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380658173012003806581730123806581730120380658173012

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/aspiration pumpA mains electricity (AC-powered), ophthalmic device used to irrigate the area pertaining to the eye and eye cavity with a fluid to provide a flushing effect during ophthalmic surgery and also to aspirate by drawing liquid out of the pertinent area. It will be used for the removal of, e.g., debris, tissue or fluids from the site, and will assist the operator by keeping the site cleared and improving the field of observation. It is commonly used during cataract operations and can generate a positive and/or negative pressure with its pumping systems and is used together with compatible instruments. This device must operate at extremely low pressure to avoid inadvertent damage to the site.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31