DEVICE: WAVENET (00380659908170)

Device Identifier (DI) Information

WAVENET
8065990817
Not in Commercial Distribution
8065990817
Alcon Laboratories, Inc.
00380659908170
GS1
September 24, 2014
1
008018525 *Terms of Use
ALLEGRETTO WAVE EYE-Q EXCIMER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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
Laser application software An individual software program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a laser for storing, processing, and managing electronic information/data used during a treatment with a laser. It is typically installed in a laser and/or interfaced with an ordinary computer (e.g., tabletop, laptop) which displays the data.
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FDA Product Code

[?]
Product Code Product Code Name
LZS Excimer Laser System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P020050 014
P030008 012
No CLOSE

Sterilization

No
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

a50088a6-e8c4-46ea-9e8d-811f5f7a552f
July 06, 2018
3
September 24, 2014
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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
No Package DIs found
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Secondary DI

[?]
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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)-862-5266
web.masterus@alcon.com
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