2.8 mm Disposable phaco set with 30° straight flared needle 8430.28SF1

GUDID 18717872031498

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

Phacoemulsification system handpiece tip, single-use

• Primary Device ID: 18717872031498
• NIH Device Record Key: 80acd422-9b07-4846-a16a-80ab20218314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.8 mm Disposable phaco set with 30° straight flared needle
• Version Model Number: 8430.28SF1
• Catalog Number: 8430.28SF1
• 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	08717872031491 [Primary]
GS1	18717872031498 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-19
• Device Publish Date: 2020-02-17

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