2.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab

GUDID 18717872033294

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

Phacoemulsification system handpiece

• Primary Device ID: 18717872033294
• NIH Device Record Key: 8cd29a0a-5c96-4a6f-b0aa-68c39114b2c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab
• Version Model Number: 3430.28AF1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08717872033297 [Primary]
GS1	18717872033294 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

[18717872033294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

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

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• 18717872034932 - 23G High Flow infusion line: 2024-02-29
• 18717872034949 - 25G High Flow infusion line: 2024-02-29
• 18717872034956 - 27G High Flow infusion line: 2024-02-29
• 18717872035106 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29
• 18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack: 2024-02-29
• 18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack: 2024-02-29
• 18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29