DEVICE: OPTI-FREE REPLENISH (00300651356090)

Device Identifier (DI) Information

OPTI-FREE REPLENISH
OPTI-FREE REPLENISH 12oz
In Commercial Distribution

Alcon Laboratories, Inc.
00300651356090
GS1

1
008018525 *Terms of Use
Opti-Free Replenish Multi-Purpose Disinfecting Solution 12oz
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Multi-purpose soft contact lens solution A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). 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 [?]
K050729 000
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

a7451956-4e0b-46ac-855e-5a8188e33e8a
July 06, 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
20300650357283 24 00300651356090 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

[?]
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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