INFRARED 800 with FLOW® 800 Option

GUDID 04049539070128

Carl Zeiss Meditec AG

Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system Surgical microscope fluorescent angiography system 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