FDA.reportPublic FDA data

PERFLUORON

Primary DI
10380659001632
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
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950018000PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)Alcon Laboratories1996-02-29LWL

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00380659001635PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00380659001642PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00757770516315Adato SIL-OL-5000Bausch & Lomb IncorporatedLWL2014-09-25