Blueprint Mixed Reality MRUE511

GUDID 03700434023145

Headset

TORNIER

Orthopaedic stereotactic surgery system

• Primary Device ID: 03700434023145
• NIH Device Record Key: 6243a484-206e-4745-b2bf-a167f1c7ad2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blueprint Mixed Reality
• Version Model Number: MRUE511
• Catalog Number: MRUE511
• Company DUNS: 260324876
• Company Name: TORNIER
• 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: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700434023145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222510

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Blueprint Mixed Reality]

• 03700434023145: Headset
• 03700434022988: BP MxR Depth Stop Pin
• 03700434022957: BP MxR Instrument Check Block
• 03700434022940: BP MxR Coracoid Clamp
• 03700434022933: BP MxR Glenoid Digitizer
• 03700434022926: BP MxR Glenoid Pin Guide
• 03700434016505: HOLOBLUEPRINT™
• 03700434023824: HOLOBLUEPRINT™