Blueprint

Basic Information

• Brand Name: Blueprint
• Primary DI: 03700434015065
• Version / Model: BPUE001
• Catalog Number: 4.0.Mac
• Company Name: TORNIER
• Labeler DUNS: 260324876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-13
• Public Version: 1
• Public Version Date: 2023-02-21
• Public Version Status: New
• Public Device Record Key: 0987a2da-7096-4f29-b5ee-f0e8bcbefb90

Device Description

Mac

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QHE	Shoulder arthroplasty implantation system	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41018	Orthopaedic CAD/CAM system	An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) orthopaedic implants typically involving the prescription forming (milling) of the femoral stem of a hip replacement for optimal fitting to that patient's bone anatomy. It typically includes three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the prosthesis to be fitted to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700434015065	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211359	000