CATALYS SYSTEM 0160-6020

GUDID 05050474617186

CATALYS SYSTEM, US, NO BED

JOHNSON & JOHNSON SURGICAL VISION, INC.

Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 05050474617186
• NIH Device Record Key: 2219d84c-1608-44b4-9ed5-0d589ef3b462
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATALYS SYSTEM
• Version Model Number: Catalys Precision Laser System
• Catalog Number: 0160-6020
• Company DUNS: 010130626
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• 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(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(800)511-0911
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474617186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172002

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: 2020-02-26
• Device Publish Date: 2018-04-19

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

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• 05050474807464 - HEALON5 PRO: 2024-04-16 HEALON5 PRO 0,6 ML US
• 05050474812765 - TECNIS ODYSSEY TORIC II IOL: 2024-02-01 TEC ODYSSEY TOR II SMPCY 31.5D CYL3.00
• 05050474812888 - TECNIS ODYSSEY TORIC II IOL: 2024-02-01 TEC ODYSSEY TOR II SMPCY 08.0D CYL3.75
• 05050474811058 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.0D CYL1.50
• 05050474811065 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.5D CYL1.50