IRR & ASP HANDPIECES BIMANUAL

GUDID 04049539102683

This single use device is an accessory for ZEISS phaco systems. It has been designed to remove the cortex and clean the capsule bag during human cataract surgery.

Carl Zeiss Meditec AG

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 04049539102683
• NIH Device Record Key: 8f603f62-e2a9-4cc5-9afb-744d90b07356
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRR & ASP HANDPIECES BIMANUAL
• Version Model Number: 303060-0165-000
• 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	04049539100191 [Primary]
GS1	04049539102683 [Package]; Contains: 04049539100191; Package: [10 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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• 04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm): 2025-05-22
• 04049539105554 - INTRABEAM SMART Spherical Applicator (35mm): 2025-05-22
• 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm): 2025-05-22
• 04049539105578 - INTRABEAM SMART Spherical Applicator (45mm): 2025-05-22