INFRARED 800 with FLOW® 800 Option

GUDID 04049539070128

Carl Zeiss Meditec AG

Surgical microscope fluorescent angiography system

• Primary Device ID: 04049539070128
• NIH Device Record Key: d68a746a-6dc9-4525-99e1-8a7f27d80e45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFRARED 800 with FLOW® 800 Option
• Version Model Number: 7012
• 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	04049539070128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100468

FDA Product Code

• IZI: System, X-Ray, Angiographic

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: 2017-04-24

On-Brand Devices [INFRARED 800 with FLOW® 800 Option]

• 04049539102362: 302581-9245-000 302581-9250-000 302581-9246-000
• 04049539070128: 7012