CONSTELLATION® ULTRAVIT® ENGAUGE®

GUDID 10380657509482

20 GA ULTRAVIT® Vitrectomy Probe

Alcon Laboratories, Inc.

Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece Vitrectomy system handpiece

• Primary Device ID: 10380657509482
• NIH Device Record Key: 0bc72ced-fcfc-4084-9980-8ab174021413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTELLATION® ULTRAVIT® ENGAUGE®
• Version Model Number: 8065750948
• 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	00380657509485 [Primary]
GS1	10380657509482 [Package]; Contains: 00380657509485; 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