Quantib ND

GUDID 08719689791216

Quantib B.V.

MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software

• Primary Device ID: 08719689791216
• NIH Device Record Key: a3cfd6da-1a64-42b4-8929-223a94baa123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantib ND
• Version Model Number: 2.1
• 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	08719689791216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213737

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: 2022-06-29
• Device Publish Date: 2022-06-21

On-Brand Devices [Quantib ND]

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