Alcon Custom-Pak

GUDID H5301ALCON1CPAK10

Alcon Custom-Pak

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: H5301ALCON1CPAK10
• NIH Device Record Key: 92119d7d-b650-4afb-b62f-ba580af5e4ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcon Custom-Pak
• Version Model Number: CPAK1
• 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: false
• 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: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com
• Phone: +18008625266
• Email: Web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H5301ALCON1CPAK10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880961

FDA Product Code

• LRO: General Surgery Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Alcon Custom-Pak]

• H5302ALCON2CPAK20: Alcon Custom-Pak
• H5301ALCON1CPAK10: Alcon Custom-Pak