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

• Primary Device ID: 00380656011873
• NIH Device Record Key: cdaa2bcb-23ca-4e26-9441-e51259ebe334
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILIKON™
• Version Model Number: 8065601187
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Dimensions

• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter
• Total Volume: 8.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380656011873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950008

FDA Product Code

• LWL: Fluid, Intraocular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-21

Devices Manufactured by Alcon Laboratories, Inc.

• 10380657530660 - UNIPURE & UNIFEYE: 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530677 - UNIPURE & UNIFEYE: 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530684 - UNIPURE & UNIPEXY: 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530691 - UNIPURE & UNIPEXY: 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated r
• 17612717072098 - FINESSE ModifEYE: 2024-10-04 25G ModifEYE Soft Tip Backflush - Long
• 17612717072104 - FINESSE ModifEYE: 2024-10-04 27+ ModifEYE Soft Tip Backflush - Long
• 17612717072067 - FINESSE ModifEYE: 2024-10-03 25G ModifEYE Soft Tip Backflush
• 17612717072074 - FINESSE ModifEYE: 2024-10-03 27+ ModifEYE Soft Tip Backflush