QUATERA 700

GUDID 04049539064073

QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. The device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation and anterior vitrectomy.

Carl Zeiss Meditec AG

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• Primary Device ID: 04049539064073
• NIH Device Record Key: e6c46906-c477-4b99-bd92-cb4f238641b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUATERA 700
• Version Model Number: REF 6407
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	04049539064073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212241

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

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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