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
00380658439668ClareonCCW0T4CCW0T4-1052026-08-27
00380658439675ClareonCCW0T4CCW0T4-1102026-08-27
00380658439682ClareonCCW0T4CCW0T4-1152026-08-27
00380658439699ClareonCCW0T4CCW0T4-1202026-08-27
00380658439705ClareonCCW0T4CCW0T4-1252026-08-27
00380658439712ClareonCCW0T4CCW0T4-1302026-08-27
00380658439729ClareonCCW0T4CCW0T4-1352026-08-27
00380658439736ClareonCCW0T4CCW0T4-1402026-08-27
00380658439743ClareonCCW0T4CCW0T4-1452026-08-27
00380658439750ClareonCCW0T4CCW0T4-1502026-08-27
00380658439767ClareonCCW0T4CCW0T4-1552026-08-27
00380658439774ClareonCCW0T4CCW0T4-1602026-08-27
00380658439781ClareonCCW0T4CCW0T4-1652026-08-27
00380658439798ClareonCCW0T4CCW0T4-1702026-08-27
00380658439804ClareonCCW0T4CCW0T4-1752026-08-27
00380658439811ClareonCCW0T4CCW0T4-1802026-08-27
00380658439828ClareonCCW0T4CCW0T4-1852026-08-27
00380658439835ClareonCCW0T4CCW0T4-1902026-08-27
00380658439842ClareonCCW0T4CCW0T4-1952026-08-27
00380658439859ClareonCCW0T4CCW0T4-2002026-08-27

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