FDA.reportPublic FDA data

PERFLUORON

Primary DI
00380659001642
Brand
PERFLUORON
Company
Alcon Laboratories, Inc.
Model
0090010016
Catalog number
8065900164
Device description
PFNO KIT 7ML
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

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
10380659001649PackageGS12In Commercial Distribution
00380659001642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065900164910380659001649
00380659001642003806590016423806590016420380659001642

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 Volume7Milliliter

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

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
10380659001632PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00757770516315Adato SIL-OL-5000Bausch & Lomb IncorporatedLWL2014-09-25