ADAS 3D

GUDID 08437021722024

ADAS3D MEDICAL S.L.

Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system Surgical simulation system

• Primary Device ID: 08437021722024
• NIH Device Record Key: 1937953e-2e59-4b77-94ac-3662faca8f35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAS 3D
• Version Model Number: V2.10
• Company DUNS: 469095791
• Company Name: ADAS3D MEDICAL 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: 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	08437021722024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212421

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: 2021-10-22
• Device Publish Date: 2021-10-14

On-Brand Devices [ADAS 3D]

• 08437021722048: V2.6
• 08437021722031: V2.8
• 08437021722024: V2.10
• 08437021722055: v2.9
• 08437021722086: V.2.12