AccessGUDID - DEVICE: WAVENET (00380659908170)

GUDID

Device Identifier (DI) Information

Brand Name: WAVENET
Version or Model: 8065990817
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8065990817
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659908170
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2014
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: ALLEGRETTO WAVE EYE-Q EXCIMER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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.

FDA Product Code

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Product Code	Product Code Name
LZS	Excimer Laser System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020050	014
P030008	012

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a50088a6-e8c4-46ea-9e8d-811f5f7a552f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014