FDA.report

SYSTANE

Primary DI
00300650190930
Brand
SYSTANE
Company
Alcon Laboratories, Inc.
Model
SYSTANE 12ml
Device description
SYSTANE Contacts Lubricant Eye Drops 12ml
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LPNAccessories, soft lens products

Product Code Classifications

CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20300650190934PackageGS124In Commercial Distribution
00300650190930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030065019093420300650190934
00300650190930003006501909303006501909300300650190930

GMDN Terms

TermDefinition
Contact lens wetting solutionAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)241-5999web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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