BLUE 400

GUDID 04049539070159

accessory for surgical microscopes

Carl Zeiss Meditec AG

Neurosurgical microscope

• Primary Device ID: 04049539070159
• NIH Device Record Key: bc4ac758-a53d-422f-917d-09ebf843497d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUE 400
• Version Model Number: 7015
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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	04049539070159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240215

FDA Product Code

• QFX: Diagnostic Neurosurgical Microscope Filter

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: 2024-10-15
• Device Publish Date: 2024-10-07

On-Brand Devices [BLUE 400]

• 04049539104342: for OPMI PENTERO 800 and OPMI PENTERO 900
• 04049539070159: accessory for surgical microscopes