EX-PRESS 8065050004

GUDID 00380650500045

EX-PRESS Glaucoma Filtration Device - Version P-50

Alcon Laboratories, Inc.

Eye valve

• Primary Device ID: 00380650500045
• NIH Device Record Key: 12cc3b3c-ac0c-4132-9e86-d5e06b7a741e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EX-PRESS
• Version Model Number: P-50
• Catalog Number: 8065050004
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Device Dimensions

• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer
• Lumen/Inner Diameter: 50 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650500045 [Primary]

FDA Product Code

• KYF: Implant, Eye Valve

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: 2025-10-01
• Device Publish Date: 2025-09-23

Devices Manufactured by Alcon Laboratories, Inc.

• 00380650500045 - EX-PRESS: 2025-10-01EX-PRESS Glaucoma Filtration Device - Version P-50
• 00380650500045 - EX-PRESS: 2025-10-01 EX-PRESS Glaucoma Filtration Device - Version P-50
• 00380652432085 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652432092 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652432108 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652432115 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652433143 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652433150 - Clareon: 2025-04-22 CLAREON TORIC UVA
• 00380652433167 - Clareon: 2025-04-22 CLAREON TORIC UVA