Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT

GUDID 10380657524515

25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator 0.9 mm Tipless Anterior Kit

Alcon Laboratories, Inc.

Vitrectomy system handpiece

• Primary Device ID: 10380657524515
• NIH Device Record Key: 934f851d-d355-43df-8ae5-69dc8eb5bd06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT
• Version Model Number: 8065752451
• 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: false
• 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	00380657524518 [Primary]
GS1	10380657524515 [Package]; Contains: 00380657524518; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093305

FDA Product Code

• MLZ: Vitrectomy, instrument cutter

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: 2018-08-20
• Device Publish Date: 2018-07-19

On-Brand Devices [Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT]

• 10380657524515: 25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoillumina
• 10380657524508: 25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminato
• 10380657524492: 23 GA TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoillumi
• 10380657524393: 27+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
• 10380657524386: 25+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
• 10380657524379: 25+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
• 10380657524362: 23 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
• 10380657524355: 23 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator