Uni Tibial Tray WZ-1-1014

GUDID B046WZ110140

Uni Tibial Tray Size 4

SIGNAL MEDICAL CORPORATION

Coated unicondylar knee tibia prosthesis

• Primary Device ID: B046WZ110140
• NIH Device Record Key: 04f0d2e7-ccad-4972-a76a-e60eb4216f05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni Tibial Tray
• Version Model Number: 4
• Catalog Number: WZ-1-1014
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046WZ110140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012800

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-13
• Device Publish Date: 2019-09-05

On-Brand Devices [Uni Tibial Tray]

• B046WZ110150: Uni Tibial Tray Size 5
• B046WZ110140: Uni Tibial Tray Size 4
• B046WZ110130: Uni Tibial Tray Size 3
• B046WZ110120: Uni Tibial Tray Size 2