QUATTRO CASSETTE

GUDID 04049539104533

The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal systems and has been designed to direct balanced salt solution from irrigation source to the surgical handpieces and to convey the materials removed from the eye to a reservoir during eye surgery on anterior and posterior segments of the human eye.

Carl Zeiss Meditec AG

Surgical irrigation/aspiration tubing set

• Primary Device ID: 04049539104533
• NIH Device Record Key: 5d86bddf-8d19-4814-acae-49ca47676872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUATTRO CASSETTE
• Version Model Number: 303061-9015-000
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• 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: true
• 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	04049539104526 [Primary]
GS1	04049539104533 [Package]; Contains: 04049539104526; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212241

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: 2022-05-03
• Device Publish Date: 2022-04-25

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