3DIEMME RealGUIDE

GUDID 08050038830010

Implants planning

3DIEMME SRL

CAD/CAM software

• Primary Device ID: 08050038830010
• NIH Device Record Key: acc4d5b0-ff25-4c38-83f3-1acdf192359b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DIEMME RealGUIDE
• Version Model Number: RealGUIDE PRO
• Company DUNS: 857172105
• Company Name: 3DIEMME SRL
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it
• Phone: +390317073353
• Email: info@3diemme.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	08050038830010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173041

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: 2019-04-03
• Device Publish Date: 2019-03-26

On-Brand Devices [3DIEMME RealGUIDE]

• 08050038830058: Full integrated planning, guide design and prosthesis modelling
• 08050038830041: Prosthesis modelling (stand-alone)
• 08050038830034: 3D diagnosis and communication module
• 08050038830027: Surgical guides modelling
• 08050038830010: Implants planning
• 08050038830003: Mobile version