VISULUX®

GUDID 04049539102430

Carl Zeiss Meditec AG

Ophthalmic slit lamp, examination

• Primary Device ID: 04049539102430
• NIH Device Record Key: 13d184a2-5650-4f5d-8ba4-794d2766b2de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISULUX®
• Version Model Number: 000000-1100-155
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539102430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161607

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-04

Devices Manufactured by Carl Zeiss Meditec AG

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• 04049539105516 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105523 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105530 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 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