GUDID 00878953000237

Zeiss Microscope Eye Protection Filter

AMERICAN MEDICAL SYSTEMS

Laser filter, optical Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter Operator eye protection laser filter

• Primary Device ID: 00878953000237
• NIH Device Record Key: c0fbe506-e46e-43ed-bbcc-5b384f5ff720
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0010-0041
• Company DUNS: 796308653
• Company Name: AMERICAN MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953000237 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS

• 00878953004822 - SureFlex 200: 2019-04-25 200 Lithotripsy Fiber
• 00878953000015 - AddStat: 2019-02-13
• 00878953000046 - EndoStat: 2019-02-13 0.2mm 12ft
• 00878953000053 - EndoStat: 2019-02-13 0.2mm 12ft SL
• 00878953000060 - EndoStat: 2019-02-13 0.3mm 12ft
• 00878953000077 - EndoStat: 2019-02-13 0.6mm 12ft
• 00878953000084 - EndoStat: 2019-02-13 0.6mm 18ft
• 00878953000091 - EndoStat: 2019-02-13 0.6mm 12ft