UNIPURE & UNIFEYE 8065753067

GUDID 10380657530677

UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.

Alcon Laboratories, Inc.

Sulfur hexafluoride refillable cylinder

• Primary Device ID: 10380657530677
• NIH Device Record Key: 3245a4ca-3a71-42d1-bcc2-fe63c8d8b1d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIPURE & UNIFEYE
• Version Model Number: 8065753067
• Catalog Number: 8065753067
• 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	00380657530670 [Primary]
GS1	10380657530677 [Package]; Contains: 00380657530670; 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