DEVICE: OPTI-CLEAN (00300650104203)

Device Identifier (DI) Information

OPTI-CLEAN
OPTI-CLEAN 20ml
In Commercial Distribution

Alcon Laboratories, Inc.
00300650104203
GS1

1
008018525 *Terms of Use
OPTI-CLEAN II Daily Cleaner 20ml
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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
Soft/rigid contact lens cleaning solution An aqueous formulation containing appropriate agents for loosening debris from reusable soft, rigid gas permeable (RGP), and hard contact lenses, often with a gentle rubbing of the lenses, to clean the lenses prior to wear. This GMDN code does not include solutions that remove protein or disinfect. The device is used mainly for daily care of the lens. After application, this device cannot be reused.
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FDA Product Code

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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

11beb7a9-a036-4f38-8d27-5c3603ce7430
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20300650104207 24 00300650104203 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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