AccessGUDID - DEVICE: Automatic Eye Safety Filter (07290109143446)

GUDID

Device Identifier (DI) Information

Brand Name: Automatic Eye Safety Filter
Version or Model: Automatic Eye Safety Filter
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LUMENIS INC.

Primary DI Number: 07290109143446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043618763 *Terms of Use

Device Description: No description.

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 filter, optical	An eyepiece to an optical system, such as an endoscope, used during a laser procedure to protect the operator's eyes from laser energy transmitted through the optics. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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
No Device Sizes

Device Record Status

Public Device Record Key: 35ceb671-e4c6-4b84-94ea-e3bcd9a41f64
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 27, 2016