FDA.reportPublic FDA data

ULTRAFLOW

Primary DI
00380658175016
Brand
ULTRAFLOW
Company
Alcon Laboratories, Inc.
Model
00380658175016
Device description
ULTRAFLOW SP IRRIGATION ONLY
Published
2018-02-28
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
NKKNEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKKNeedle, Hypodermic, Single Lumen, ReprocessedGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380658175016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380658175016003806581750163806581750160380658175016

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)241-5999web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
G079C5020000450Golden Isles Pedicle Screw SystemIntelivation, LLCNKK2022-10-03
00850033297010Kova PlasticsAlltrista Plastics LLCNKK2021-07-29
00380657510122INTREPID®Alcon Laboratories, Inc.NKK2020-09-02
00380657510139INTREPID®Alcon Laboratories, Inc.NKK2020-09-02
00380657409693ALCONAlcon Laboratories, Inc.NKK2017-06-08
00380657409709ALCONAlcon Laboratories, Inc.NKK2017-06-08
10380657409690ALCONAlcon Laboratories, Inc.NKK2017-06-08
10380657409706ALCONAlcon Laboratories, Inc.NKK2017-06-08
00380657517954ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07
00380658170011ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07
00380658172015ULTRA FLOWAlcon Laboratories, Inc.NKK2017-06-07