LenSx® SoftFit™

GUDID 00380659982750

LenSx® SoftFit™ Patient Interface Steep

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic surgical procedure kit, non-medicated, single-use Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup Ophthalmic laser system eyeball positioning suction cup

• Primary Device ID: 00380659982750
• NIH Device Record Key: 3747c7bb-be35-4e41-b722-01cdd7a3a3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LenSx® SoftFit™
• Version Model Number: 8065998275
• 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: 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
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• Phone: +1(800)862-5266
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• Phone: +1(800)862-5266
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• 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
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• 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
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• 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
• 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
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• Phone: +1(800)862-5266
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• Phone: +1(800)862-5266
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• Phone: +1(800)862-5266
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• Phone: +1(800)862-5266
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• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
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• 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
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• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659982750 [Primary]
GS1	20380659982754 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163551

FDA Product Code

• HQC: Unit, phacofragmentation

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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [LenSx® SoftFit™]

• 00380659982767: LenSx® SoftFit™ Patient Interface Flat
• 00380659982750: LenSx® SoftFit™ Patient Interface Steep
• 00380659982743: LenSx® SoftFit™ Patient Interface Nominal