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

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
00380658561345CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0652026-11-03
00380658561352CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0702026-11-03
00380658561369CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0752026-11-03
00380658561376CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0802026-11-03
00380658561383CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0852026-11-03
00380658561390CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0902026-11-03
00380658561406CLAREON VIVITY PRO TORICVNYWT3VNYWT3-0952026-11-03
00380658561413CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1002026-11-03
00380658561420CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1052026-11-03
00380658561437CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1102026-11-03
00380658561444CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1152026-11-03
00380658561451CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1202026-11-03
00380658561468CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1252026-11-03
00380658561475CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1302026-11-03
00380658561482CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1352026-11-03
00380658561499CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1402026-11-03
00380658561505CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1452026-11-03
00380658561512CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1502026-11-03
00380658561529CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1552026-11-03
00380658561536CLAREON VIVITY PRO TORICVNYWT3VNYWT3-1602026-11-03

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