CATALYS SYSTEM CATALYS-U

GUDID 05050474609792

CATALYS SYSTEM, US

OPTIMEDICA CORPORATION

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 05050474609792
• NIH Device Record Key: a1163083-cb96-4a39-8f61-0e78f5ad83ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATALYS SYSTEM
• Version Model Number: CATALYS-U
• Catalog Number: CATALYS-U
• Company DUNS: 151018996
• Company Name: OPTIMEDICA CORPORATION
• 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: false
• 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

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474609792 [Primary]

FDA Product Code

• OOE: Ophthalmic femtosecond laser

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-02

On-Brand Devices [CATALYS SYSTEM]

• 05050474609792: CATALYS SYSTEM, US
• 05050474709508: CATALYS ELEVATED SYS ACCY,USE W/MPB,US