SILIKON 8065601185
GUDID 00380656011859
SILIKON 1000 8.5ML VIAL Purified polydimethylsiloxane
Alcon Laboratories, Inc.
Aqueous/vitreous humour replacement medium kit| Primary Device ID | 00380656011859 |
| NIH Device Record Key | 866b18d3-219b-4497-83d3-87c4f10eaa90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SILIKON |
| Version Model Number | 8065601185 |
| Catalog Number | 8065601185 |
| 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 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| web.masterus@alcon.com | |
| Phone | +1(800)-862-5266 |
| 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 |
| 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 | 00380656011859 [Primary] |
| GS1 | 10380656011856 [Package] Package: Box [160 Units] In Commercial Distribution |
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 | 2016-02-12 |
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 |
Trademark Results [SILIKON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SILIKON 75330872 2476037 Live/Registered |
NOVARTIS AG 1997-07-25 |
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