SILIKON™

Primary DI
00380656011873
Brand
SILIKON™
Company
Alcon Laboratories, Inc.
Model
8065601187
Device description
SILIKON™ 1000 (purified polydimethylsiloxane) is highly purified long chain polydimethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile,non-pyrogenic, clear, colorless and has a viscosity of 1000 cs. for use as a post-operative retinal tamponade during vitreoretinal surgery. SILIKON™ 1000is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material withlittle biological toxicity potential.
Published
2015-08-21
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
P950008012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950008012SILIKON 1000Alcon1997-09-25LWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380656011873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380656011873003806560118733806560118730380656011873

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 Volume8.5Milliliter

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
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
00380659001635PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
10380659001632PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00380659001642PERFLUORONAlcon Laboratories, Inc.LWL2015-03-06
00757770516315Adato SIL-OL-5000Bausch & Lomb IncorporatedLWL2014-09-25