Cypass

GUDID 00380657540075

CYPASS ULTRA SYSTEM CYPASS MICRO-STENT CYPASS' APPLIER

Alcon Laboratories, Inc.

Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt

• Primary Device ID: 00380657540075
• NIH Device Record Key: bc0746c1-da50-4ddb-acf3-a70779b5531c
• Commercial Distribution Discontinuation: 2018-08-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cypass
• Version Model Number: 8065754007
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380657540075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150037

FDA Product Code

• OGO: Intraocular pressure lowering implant

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-23
• Device Publish Date: 2018-07-19

On-Brand Devices [Cypass]

• 00380657540075: CYPASS ULTRA SYSTEM CYPASS MICRO-STENT CYPASS' APPLIER
• 10380657540034: CyPass System