CONSTELLATION HYPERVIT ENGAUGE

GUDID 10380658300262

CONSTELLATION 25+ HYPERVIT Bevel, Vitrectomy Probe 20,000 cpm

Alcon Laboratories, Inc.

Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit Vitrectomy system micro-cutting unit

• Primary Device ID: 10380658300262
• NIH Device Record Key: 041fed3d-58d2-4819-b46e-430f49ca5737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSTELLATION HYPERVIT ENGAUGE
• Version Model Number: 8065830026
• 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
• 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	00380658300265 [Primary]
GS1	10380658300262 [Package]; Contains: 00380658300265; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170520

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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [CONSTELLATION HYPERVIT ENGAUGE]

• 10380658300279: CONSTELLATION 27+ HYPERVIT Bevel, Vitrectomy Probe 20,000 cpm
• 10380658300262: CONSTELLATION 25+ HYPERVIT Bevel, Vitrectomy Probe 20,000 cpm