LenSx, Alcon

GUDID 10380659982252

LENSX LASER SOFTFIT PATIENT

Alcon Laboratories, Inc.

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

• Primary Device ID: 10380659982252
• NIH Device Record Key: f857f6df-c3e8-4d16-90b3-274a4aefbb89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LenSx, Alcon
• Version Model Number: 8065998225
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659982255 [Primary]
GS1	10380659982252 [Package]; Contains: 00380659982255; Package: Box [10 Units]; In Commercial Distribution
GS1	20380659982259 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• HQC: Unit, phacofragmentation

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: 2019-11-08
• Device Publish Date: 2016-09-24

Devices Manufactured by Alcon Laboratories, Inc.

• 10380657530660 - UNIPURE & UNIFEYE: 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530677 - UNIPURE & UNIFEYE: 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530684 - UNIPURE & UNIPEXY: 2024-11-05 UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated
• 10380657530691 - UNIPURE & UNIPEXY: 2024-11-05 UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated r
• 17612717072098 - FINESSE ModifEYE: 2024-10-04 25G ModifEYE Soft Tip Backflush - Long
• 17612717072104 - FINESSE ModifEYE: 2024-10-04 27+ ModifEYE Soft Tip Backflush - Long
• 17612717072067 - FINESSE ModifEYE: 2024-10-03 25G ModifEYE Soft Tip Backflush
• 17612717072074 - FINESSE ModifEYE: 2024-10-03 27+ ModifEYE Soft Tip Backflush