NA

Basic Information

• Brand Name: NA
• Primary DI: 00878953000244
• Version / Model: 0010-0045
• Company Name: AMERICAN MEDICAL SYSTEMS
• Labeler DUNS: 796308653
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2025-07-10
• Public Version Status: Update
• Public Device Record Key: dfbd9221-97a7-454d-b40c-b334986fd7fa
• Distribution End Date: 2019-10-25

Device Description

Zeiss Microscope Eye Protection Filter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878953000244	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Optical Density 5 at 532nm and 1064nm