Blueprint 4.1.Mac

GUDID 03700434023107

MAC

TORNIER

Orthopaedic CAD/CAM system

• Primary Device ID: 03700434023107
• NIH Device Record Key: 01c7a3e8-c17f-4e61-9c11-79e5d3fcf751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blueprint
• Version Model Number: BPUE001
• Catalog Number: 4.1.Mac
• 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: false
• 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	03700434023107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232265

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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: 2024-03-22
• Device Publish Date: 2024-03-14

On-Brand Devices [Blueprint]

• 03700386988783: BLUEPRINT REUSABLE PIN GUIDE
• 03700434023114: WIN
• 03700434023107: MAC
• 03700434015065: Mac
• 03700434015058: Win
• 03700434023848: WIN
• 03700434023831: MAC