SurgiCase Planner SurgiCase Shoulder Planner

GUDID E314SURGICASESHOULPLAN0

SurgiCase Shoulder Planner

Materialise NV

CAD/CAM software

• Primary Device ID: E314SURGICASESHOULPLAN0
• NIH Device Record Key: d48e7acb-3014-4fda-8559-38ef63c6f95f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiCase Planner
• Version Model Number: SurgiCase Shoulder Planner
• Catalog Number: SurgiCase Shoulder Planner
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E314SURGICASESHOULPLAN0 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-19
• Device Publish Date: 2018-10-17

On-Brand Devices [SurgiCase Planner ]

• E314SURGICASESHOULPLAN0: SurgiCase Shoulder Planner
• E314SURGICASEPLANNER0: SurgiCase Planner
• E314SURGICASEKNEEPLAN0: SurgiCase Knee Planner