Infiniti

GUDID 00380657501212

Ultrasonic Handpiece

Alcon Laboratories, Inc.

Phacoemulsification system handpiece Phacoemulsification system handpiece

• Primary Device ID: 00380657501212
• NIH Device Record Key: 01aebed9-c0d3-4271-a24b-de95b991d1fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infiniti
• Version Model Number: 8065750121
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380657501212 [Primary]

FDA Product Code

• HQC: Unit, phacofragmentation

Sterilization

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

[00380657501212]

Moist Heat or Steam Sterilization

[00380657501212]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-06-07

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• 00380657521609: Infiniti Vision System
• 00380657504688: Infiniti Remote control
• 00380657504039: Enhanced Footswitch, Infiniti
• 10380657502933: Infiniti Ultrasound Multipak Basic Stand Alone
• 10380657501578: Anterior Vitrectomy Pak: Anterior Vitrectomy Probe w/21 GA Infusion Cannula
• 00380657501212: Ultrasonic Handpiece