FDA.reportPublic FDA data

PERFLUORON

Primary DI
00380659001635
Brand
PERFLUORON
Company
Alcon Laboratories, Inc.
Model
0090010015
Catalog number
8065900163
Device description
PFNO KIT 5ML
Published
2015-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWLFluid, Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWLFluid, IntraocularOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380659001632PackageGS13In Commercial Distribution
00380659001635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065900163210380659001632
00380659001635003806590016353806590016350380659001635

GMDN Terms#

Term, Definition table
TermDefinition
Aqueous/vitreous humour replacement medium kitA collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
00380656011859SILIKONAlcon Laboratories, Inc.LWL2016-02-12
00380656011873SILIKON™Alcon Laboratories, Inc.LWL2015-08-21
10380659001632PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00380659001642PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00757770516315Adato SIL-OL-5000Bausch & Lomb IncorporatedLWL2014-09-25