SILIKON

Basic Information

• Brand Name: SILIKON
• Primary DI: 00380656011859
• Version / Model: 8065601185
• Catalog Number: 8065601185
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-12
• Public Version: 4
• Public Version Date: 2022-01-24
• Public Version Status: Update
• Public Device Record Key: 866b18d3-219b-4497-83d3-87c4f10eaa90

Device Description

SILIKON 1000 8.5ML VIAL Purified polydimethylsiloxane

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWL	Fluid, Intraocular	Ophthalmic	886.4275	3

GMDN Terms

Code	Name	Definition	Implantable	Status
36108	Aqueous/vitreous humour replacement medium kit	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380656011859	GS1
Package	10380656011856	GS1	Box	160	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	8.5	Milliliter