CALLISTO eye Software

GUDID 04049539070302

Carl Zeiss Meditec AG

Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system

• Primary Device ID: 04049539070302
• NIH Device Record Key: a6795aa1-c7bf-45ae-a7b1-a143264ea96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALLISTO eye Software
• Version Model Number: 5
• 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: true
• Serial Number: false
• 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	04049539070302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232944

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2024-06-14
• Device Publish Date: 2024-06-06

Devices Manufactured by Carl Zeiss Meditec AG

• 04049539069214 - CALLISTO eye Panel PC: 2024-06-14
• 04049539070302 - CALLISTO eye Software: 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
• 04049471100167 - Treatment Pack (Type KP): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100136 - Treatment Pack (Size S): 2024-02-16 single use accessory for ZEISS femtosecond lasers
• 04049539101341 - EyeMag Smart: 2023-11-16