SYSTANE

Basic Information

• Brand Name: SYSTANE
• Primary DI: 00300650190930
• Version / Model: SYSTANE 12ml
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 49805c8b-2be9-4979-851a-bc4a60862a72

Device Description

SYSTANE Contacts Lubricant Eye Drops 12ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
LPN	Accessories, soft lens products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48082	Contact lens wetting solution	An aqueous formulation intended to wet contact lenses. The device is dispensed as droplets typically directly on the eyes while the patient wears the contact lenses; it is available in single- or multiple-dose containers. After application, this device cannot be reused.	No	Active
44237	Eye lubricant	A substance intended to provide supplemental lubrication/hydration to the natural eye to treat dry, tired, irritated, and/or strained eyes resulting from dry eye syndrome, ageing/hormone changes (menopause), or environmental factors (e.g., medications, pollution, computer use, air conditioning, allergy); some types may in addition be intended to wet contact lenses during wear. It may be a topical solution, spray, suspension, or gel applied to the eyes or eyelids, and may have special formulations (e.g., intensive, night use). It is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00300650190930	GS1
Package	20300650190934	GS1	Case	24	In Commercial Distribution

Customer Contacts

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