Trabexus® 130703-05

GUDID W4146EB0005T0475

Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.

Vivorte, Inc

Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft

• Primary Device ID: W4146EB0005T0475
• NIH Device Record Key: 2e59a0c7-5ad1-444c-8c8c-e9052f523edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabexus®
• Version Model Number: 5 cc
• Catalog Number: 130703-05
• Company DUNS: 078400984
• Company Name: Vivorte, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
ICCBBA	W4146EB0005T0475 [Primary]

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2021-07-30
• Device Publish Date: 2016-01-28

On-Brand Devices [Trabexus®]

• W4146EB0005T0475: Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name
• W4146EB0003T0475: Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand nam