i-SPEAR

GUDID 10380651000060

i-SPEAR Ophthalmic Sponge

Alcon Laboratories, Inc.

Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge

• Primary Device ID: 10380651000060
• NIH Device Record Key: 98e56bd7-fb30-4750-9b75-d1cffb7a8454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-SPEAR
• Version Model Number: 8065100006
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 6
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650705044 [Unit of Use]
GS1	00380651000063 [Primary]
GS1	10380651000060 [Package]; Contains: 00380651000063; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896004

FDA Product Code

• HOZ: Sponge, ophthalmic

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: 2016-09-24

On-Brand Devices [i-SPEAR]

• 10380651000107: i-SPEAR Ophthalmic Sponge
• 10380651000060: i-SPEAR Ophthalmic Sponge