CENTURION®, INTREPID®

GUDID 10380657531353

CENTURION® Vision System Active FMS w/ INTREPID Ultra Sleeves, 0.9MM 45° ABS* INTERPID Hybrid Tip

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10380657531353
• NIH Device Record Key: 9b6ea049-2a73-4617-b7ad-9015c8d6c21d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTURION®, INTREPID®
• Version Model Number: 8065753135
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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)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	00380657531356 [Primary]
GS1	10380657531353 [Package]; Contains: 00380657531356; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121555

FDA Product Code

• HQC: Unit, phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-02
• Device Publish Date: 2019-11-22

On-Brand Devices [CENTURION®, INTREPID®]

• 10380657531599: CENTURION® Vision System Active FMS w/ 0.9MM Infusion Sleeves 0.9MM 45° ABS* INTREPID Hybrid T
• 10380657531438: CENTURION® Vision System Gravity FMS w/ INTREPID® Ultra Sleeves 0.9MM 45° ABS* INTREPID Hybri
• 10380657531377: CENTURION® Vision System Active FMS w/ INTREPID Nano Sleeves, 0.9MM 45° ABS* INTERPID Hybrid
• 10380657531353: CENTURION® Vision System Active FMS w/ INTREPID Ultra Sleeves, 0.9MM 45° ABS* INTERPID Hybrid