CENTURION®

GUDID 00380657529148

Centurion Vision System Active Sentry® Handpiece

Alcon Laboratories, Inc.

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