CONSTELLATION® ULTRAVIT® ENGAUGE®

GUDID 10380657509505

25 GA ULTRAVIT® Vitrectomy Probe

Alcon Laboratories, Inc.

Vitrectomy system handpiece

• Primary Device ID: 10380657509505
• NIH Device Record Key: cfcb9ed9-0aae-4e45-a227-bbbd21e322c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTELLATION® ULTRAVIT® ENGAUGE®
• Version Model Number: 8065750950
• 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: 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	00380657509508 [Primary]
GS1	10380657509505 [Package]; Contains: 00380657509508; 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: 2020-01-24
• Device Publish Date: 2020-01-16

On-Brand Devices [CONSTELLATION® ULTRAVIT® ENGAUGE®]

• 10380657517043: 25+ Short ULTRAVIT® Vitrectomy Probe
• 10380657517005: 27+ ULTRAVIT® Vitrectomy Probe
• 10380657514387: 25+ ULTRAVIT® Vitrectomy Probe
• 10380657509505: 25 GA ULTRAVIT® Vitrectomy Probe
• 10380657509499: 23 GA ULTRAVIT® Vitrectomy Probe
• 10380657509482: 20 GA ULTRAVIT® Vitrectomy Probe