INTRABEAM® PRS 500

GUDID 04049539064028

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system

• Primary Device ID: 04049539064028
• NIH Device Record Key: 0e0bf1b0-e522-4958-b8f6-737e46e0273f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRABEAM® PRS 500
• Version Model Number: 304534-0000-500
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049539064028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051055

FDA Product Code

• JAD: System, Therapeutic, X-Ray

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: 2016-09-23

Devices Manufactured by Carl Zeiss Meditec AG

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• 04049539106094 - SMARTDRAPE: 2025-01-30
• 04049539106889 - EyeMag Smart TTL: 2025-01-30
• 04049539106896 - EyeMag Classic: 2025-01-30
• 04049471095074 - MEL 90: 2024-12-23 The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue ac
• 04049471095111 - VISUMAX: 2024-12-23 The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in th