AccessGUDID - DEVICE: Automatic Eye Safety Filter (07290109143446)

GUDID

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

Primary DI Number: 07290109143446
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

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 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.

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 27, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Phone: 408-764-3000
Email: xxx@xxx.xxx