Uni Tibial Insert WZ-1-1035

GUDID B046WZ110350

Uni Tibial Insert 4x14

SIGNAL MEDICAL CORPORATION

Tibial insert

• Primary Device ID: B046WZ110350
• NIH Device Record Key: 5a33408e-441a-4a36-858d-c3327c3d0415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni Tibial Insert
• Version Model Number: 4x14
• Catalog Number: WZ-1-1035
• 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: jgorney@signalmd.com
• Phone: 8103647070
• Email: jgorney@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046WZ110350 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

On-Brand Devices [Uni Tibial Insert]

• B046WZ110450: Uni Tibial Insert 5x8
• B046WZ110440: Uni Tibial Insert 4x8
• B046WZ110430: Uni Tibial Insert 3x8
• B046WZ110420: Uni Tibial Insert 2x8
• B046WZ110410: Uni Tibial Insert 1x8
• B046WZ110390: Uni Tibial Insert 5x14
• B046WZ110380: Uni Tibial Insert 5x12
• B046WZ110370: Uni Tibial Insert 5x10
• B046WZ110350: Uni Tibial Insert 4x14
• B046WZ110340: Uni Tibial Insert 4x12
• B046WZ110330: Uni Tibial Insert 4x10
• B046WZ110310: Uni Tibial Insert 3x14
• B046WZ110300: Uni Tibial Insert 3x12
• B046WZ110290: Uni Tibial Insert 3x10
• B046WZ110270: Uni Tibial Insert 2x14
• B046WZ110260: Uni Tibial Insert 2x12
• B046WZ110250: Uni Tibial Insert 2x10
• B046WZ110230: Uni Tibial Insert 1x14
• B046WZ110220: Uni Tibial Insert 1x12
• B046WZ110210: Uni Tibial Insert 1x10