AccessGUDID - DEVICE: Fixed Eye Safety Filter (07290109143583)

GUDID

Device Identifier (DI) Information

Brand Name: Fixed Eye Safety Filter
Version or Model: Fixed Eye Safety Filter
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LUMENIS INC.

Primary DI Number: 07290109143583
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2023
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36308	Operator eye protection laser filter	An eyepiece intended to be fitted to a device used during a laser procedure (e.g., surgical laser system, endoscope, surgical microscope) to protect the operator's eyes from laser energy. This is a reusable device.	Active	false

FDA Product Code

[?]

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: 5bd8e51a-be71-4a4d-baf1-530175c2d4b1
Public Version Date: August 01, 2023
Public Version Number: 4
DI Record Publish Date: September 25, 2016