UNIPURE & UNIFEYE 8065753066

GUDID 10380657530660

UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.

Alcon Laboratories, Inc.

Perfluoropropane refillable cylinder

• Primary Device ID: 10380657530660
• NIH Device Record Key: c7a790ae-bae5-47d5-9f20-d3bd1880cbce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIPURE & UNIFEYE
• Version Model Number: 8065753066
• Catalog Number: 8065753066
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380657530663 [Primary]
GS1	10380657530660 [Package]; Contains: 00380657530663; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• LPO: Gases Used Within Eye To Place Pressure On Detached Retina

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: 2024-11-05
• Device Publish Date: 2024-10-28

On-Brand Devices [UNIPURE & UNIFEYE]

• 10380657530677: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System
• 10380657530660: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System