20G Disposable phaco fragmentation needle, incl. wrench

GUDID 18717872033041

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

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• Primary Device ID: 18717872033041
• NIH Device Record Key: 7528dccc-3a68-4d7f-9cb7-c86f2796d2e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20G Disposable phaco fragmentation needle, incl. wrench
• Version Model Number: 8400.FT
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 3
• 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	08717872033044 [Primary]
GS1	18717872033041 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

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