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

• 04049539106704 - Single-use lenses for RESIGHT, MACULA LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106735 - Single-use lenses for RESIGHT, WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106766 - Single-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539069214 - CALLISTO eye Panel PC: 2024-06-14
• 04049539070302 - CALLISTO eye Software: 2024-06-14
• 04049539066497 - ARTEVO 750/850: 2024-05-22 ARTEVO 750/850 is a surgical microscope intended for the magnification of the surgical area and for the visualization in surgica
• 04049471100143 - Treatment Pack (Size M): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100150 - Treatment Pack (Size L): 2024-02-19 single use accessory for ZEISS femtosecond lasers