Bonelogic

GUDID 06429810209221

Disior Oy

CAD/CAM software

• Primary Device ID: 06429810209221
• NIH Device Record Key: 7906c802-dab3-4d19-8aa0-a69d7aaea1ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonelogic
• Version Model Number: Bonelogic 2.2
• Company DUNS: 368480395
• Company Name: Disior Oy
• 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	06429810209221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223757

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: 2024-01-23
• Device Publish Date: 2024-01-15

On-Brand Devices [Bonelogic]

• 06429810209023: Bonelogic 2
• 06429810209221: Bonelogic 2.2