DEVICE: SYSTANE (00300650190930)

Device Identifier (DI) Information

SYSTANE
SYSTANE 12ml
In Commercial Distribution

Alcon Laboratories, Inc.
00300650190930
GS1

1
008018525 *Terms of Use
SYSTANE Contacts Lubricant Eye Drops 12ml
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
Eye lubricant A sterile substance intended to provide supplemental lubrication/hydration to the natural eye to treat dry, tired, and/or strained eyes resulting from dry eye syndrome, ageing/hormone changes (menopause), or environmental factors (e.g., medications, pollution, computer use, air conditioning); 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 normally available [non-prescription] over-the-counter (OTC) for home-use (single dose or multidose). After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
LPN Accessories, soft lens products
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

49805c8b-2be9-4979-851a-bc4a60862a72
May 23, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20300650190934 24 00300650190930 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)241-5999
web.masterus@alcon.com
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