CENTURION®

GUDID 00380657529148

Centurion Vision System Active Sentry® Handpiece

Alcon Laboratories, Inc.

Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece

• Primary Device ID: 00380657529148
• NIH Device Record Key: 623fdbb4-80c7-40e4-8a2d-0ea8ee74aadd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTURION®
• Version Model Number: 8065752914
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380657529148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161794

FDA Product Code

• HQC: Unit, phacofragmentation

Sterilization

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

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

[00380657529148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-03
• Device Publish Date: 2019-12-19

On-Brand Devices [CENTURION®]

• 00380657529148: Centurion Vision System Active Sentry® Handpiece
• 00380657525270: CENTURION® VISION SYSTEM RECONSTITUTION RACK