ULTRA FLOW

GUDID 00380658176013

ULTRAFLOW S/P CURVED TIP, .3 mm

Alcon Laboratories, Inc.

Ophthalmic irrigation/aspiration pump

• Primary Device ID: 00380658176013
• NIH Device Record Key: 199a9309-e2b8-41fa-a3c7-4dbaaea1e989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA FLOW
• Version Model Number: 8065817601
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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)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	00380658176013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112425

FDA Product Code

• HQC: Unit, phacofragmentation

Sterilization

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

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

[00380658176013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-09

On-Brand Devices [ULTRA FLOW]

• 00380658176013: ULTRAFLOW S/P CURVED TIP, .3 mm
• 00380658173012: ULTRAFLOW S/P 90 BENT TIP, .3 mm
• 00380658172015: ULTRAFLOW S/P 45 BENT TIP, .3MM
• 00380658170011: ULTRAFLOW S/P STRAIGHT TIP, .3MM
• 00380657517954: ULTRAFLOW II I/A HANDPIECE