AccessGUDID - DEVICE: WAVELIGHT REFRACTIVE SUITE (00380659907463)

GUDID

Device Identifier (DI) Information

Brand Name: WAVELIGHT REFRACTIVE SUITE
Version or Model: 8065990746
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659907463
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: REFRACTIVE SUITE SWIVEL BED

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15723	Ophthalmic chair, line-powered	A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZS	Excimer Laser System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Weight: 800 Pound

Device Record Status

Public Device Record Key: c1661a28-531f-4dae-9322-55e28041dc49
Public Version Date: March 22, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2014