CALLISTO eye

GUDID 04049539069092

Carl Zeiss Meditec AG

Operating room audiovisual data/device management system

• Primary Device ID: 04049539069092
• NIH Device Record Key: 661aaa47-7091-4e55-86a0-fe9cf387c0fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALLISTO eye
• Version Model Number: 3.5.1
• 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: true
• 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	04049539069092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141068

FDA Product Code

• EPT: Microscope, Surgical

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: 2016-09-22

On-Brand Devices [CALLISTO eye]

• 04049539104366: CALLISTO eye
• 04049539102423: 3.2.1
• 04049539069092: 3.5.1