PERFLUORON 8065900163

GUDID 10380659001632

PFNO KIT 5ML

Alcon Laboratories, Inc.

Aqueous/vitreous humour replacement medium kit

• Primary Device ID: 10380659001632
• NIH Device Record Key: a4e4c8ad-c906-4a00-815a-3369e876cdcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFLUORON
• Version Model Number: 0090010015
• Catalog Number: 8065900163
• 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: true
• 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: 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

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659001635 [Primary]
GS1	10380659001632 [Package]; Contains: 00380659001635; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950018

FDA Product Code

• LWL: Fluid, Intraocular

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: 2018-07-06
• Device Publish Date: 2015-03-06

On-Brand Devices [PERFLUORON]

• 00380659001642: PFNO KIT 7ML
• 10380659001632: PFNO KIT 5ML