Quantib Brain

GUDID 08719689791254

Quantib B.V.

MRI system application software

• Primary Device ID: 08719689791254
• NIH Device Record Key: 585f5edd-ab84-424b-b39a-815843db0064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantib Brain
• Version Model Number: 1.5
• Company DUNS: 490216247
• Company Name: Quantib B.V.
• 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: false
• 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	08719689791254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173939

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [Quantib Brain]

• 08719689791070: 1.4
• 08719689791254: 1.5