Trabexus ® 131133-03

GUDID 00868201000102

Calcium compound bone void filler (3cc)

Vivorte, Inc

Bone matrix implant, synthetic

• Primary Device ID: 00868201000102
• NIH Device Record Key: d9478013-b719-41fe-a114-cf17abdf1f2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabexus ®
• Version Model Number: 3 cc
• Catalog Number: 131133-03
• 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868201000102 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-19

On-Brand Devices [Trabexus ®]

• 00868201000126: Calcium compound bone void filler (10 cc)
• 00868201000119: Calcium compound bone void filler (5 cc)
• 00868201000102: Calcium compound bone void filler (3cc)