EVA NEXUS™ Irrigation and Aux. Aspiration Tubing

GUDID 18717872031795

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 18717872031795
• NIH Device Record Key: 8ea66d35-9a38-46b0-b10c-a78892f6f83a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA NEXUS™ Irrigation and Aux. Aspiration Tubing
• Version Model Number: 9110.IAD01
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08717872031798 [Primary]
GS1	18717872031795 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213467

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: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [EVA NEXUS™ Irrigation and Aux. Aspiration Tubing]

• 18717872031795: 9110.IAD01
• 08717872036489: 9110.IAD01-00