SILIKON™

GUDID 00380656011873

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™ 1000 is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material with little biological toxicity potential.

Alcon Laboratories, Inc.

Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit Aqueous/vitreous humour replacement medium kit
Primary Device ID00380656011873
NIH Device Record Keycdaa2bcb-23ca-4e26-9441-e51259ebe334
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILIKON™
Version Model Number8065601187
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com

Device Dimensions

Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter
Total Volume8.5 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100380656011873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWLFluid, Intraocular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-21

Devices Manufactured by Alcon Laboratories, Inc.

10380650002362 - UNITY TETRASPOT2024-07-11 25GA TETRASPOT MultiSpot Laser Probe
10380650002379 - UNITY TETRASPOT2024-07-11 27GA TETRASPOT MultiSpot Laser Probe
00380650002433 - UNITY2024-07-11 LASER KIT
10380650002515 - ALCON2024-07-11 27GA Illuminated Flexible Curved Laser Probe
00380650002969 - UNITY2024-07-11 UNITY VCS System (Anterior/Posterior)
10380650003390 - UNITY2024-07-11 UNITY Cataract FMS Pack, 30° Balanced Tip with Ultra Infusion Sleeves
10380650003406 - UNITY2024-07-11 UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves
10380650003413 - UNITY2024-07-11 UNITY Cataract FMS Pack, 30° Hybrid Tip with Ultra Infusion Sleeves

Trademark Results [SILIKON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILIKON
SILIKON
75330872 2476037 Live/Registered
NOVARTIS AG
1997-07-25
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.