ADAS 3D

GUDID 08437021722048

ADAS3D MEDICAL S.L.

Surgical simulation system

• Primary Device ID: 08437021722048
• NIH Device Record Key: f85f5529-d021-43e0-b17c-0b7dec0e13e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAS 3D
• Version Model Number: V2.6
• 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	08437021722048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191125

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