Quantib ND

GUDID 08719689791148

Quantib B.V.

MRI system application software

• Primary Device ID: 08719689791148
• NIH Device Record Key: ba79003a-b62a-4e60-a453-0d14697b2a0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantib ND
• Version Model Number: 1.8
• 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	08719689791148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182564

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: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [Quantib ND]

• 08719689791032: 1.6
• 08719689791094: 1.7
• 08719689791148: 1.8
• 08719689791179: 2.0
• 08719689791216: 2.1
• 08719689791261: 2.2