SurgiCase Planner SurgiCase Planner

GUDID E314SURGICASEPLANNER0

SurgiCase Planner

Materialise NV

CAD/CAM software

• Primary Device ID: E314SURGICASEPLANNER0
• NIH Device Record Key: d38de10d-d11c-43a7-b426-e20d2273a4c5
• Commercial Distribution Discontinuation: 2020-01-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SurgiCase Planner
• Version Model Number: SurgiCase Planner
• Catalog Number: SurgiCase 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	E314SURGICASEPLANNER0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150928

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-03
• Device Publish Date: 2017-02-10

On-Brand Devices [SurgiCase Planner]

• E314SURGICASESHOULPLAN0: SurgiCase Shoulder Planner
• E314SURGICASEPLANNER0: SurgiCase Planner
• E314SURGICASEKNEEPLAN0: SurgiCase Knee Planner
• 05404028000922: SurgiCase Knee Planner
• 05404028001028: SurgiCase Shoulder Planner