Zimmer Zimmer PSIP

GUDID E314ZIMMERPSIP0

Zimmer PSIP

Materialise NV

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software

• Primary Device ID: E314ZIMMERPSIP0
• NIH Device Record Key: 0147cf04-f7fb-433b-906d-aa7c3061de55
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zimmer
• Version Model Number: Zimmer PSIP
• Catalog Number: Zimmer PSIP
• 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	E314ZIMMERPSIP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140027

FDA Product Code

• MBV: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, 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: 2019-07-19
• Device Publish Date: 2017-02-10

On-Brand Devices [Zimmer ]

• E314ZIMMERPSIP0: Zimmer PSIP
• E314ZIMMERPSIOMS0: Zimmer online management system