LENSX

GUDID 10380650000535

LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO

Alcon Laboratories, Inc.

Ophthalmic laser system eyeball positioning suction cup

• Primary Device ID: 10380650000535
• NIH Device Record Key: bbadb1f2-3f80-4171-a3c8-b477ca20f37f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LENSX
• Version Model Number: 8065000053
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650000538 [Primary]
GS1	10380650000535 [Package]; Contains: 00380650000538; Package: [10 Units]; In Commercial Distribution
GS1	20380650000532 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [LENSX]

• 00380659981623: LenSx Laser System
• 10380650000573: LENSXPATIENT INTERFACE FLAP 10PK,EO
• 20380650000563: LENSX SOFTFIT PATIENT INTERFACEI FLAT,EO
• 20380650000556: LENSX SOFTFIT PATIENT INTERFACE STEEP,EO
• 20380650000549: LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
• 10380650000535: LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO