ANKYRAS

GUDID 08437025622016

MENTICE SPAIN S.L.

Surgical simulation system

• Primary Device ID: 08437025622016
• NIH Device Record Key: 6d9d0437-4acd-4fe2-bc39-43e30ab985d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANKYRAS
• Version Model Number: v4.0.4-US
• Company DUNS: 471570274
• Company Name: MENTICE SPAIN S.L.
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08437025622016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250160

FDA Product Code

• PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices

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: 2026-03-06
• Device Publish Date: 2026-02-26