Fortera 131133-05-S

GUDID 00868201000171

Calcium compound bone void filler (5 cc)

Vivorte, Inc

Bone matrix implant, synthetic

• Primary Device ID: 00868201000171
• NIH Device Record Key: 5d8c8214-b914-4e4b-82b4-f0cd5c367ce4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortera
• Version Model Number: 5 cc
• Catalog Number: 131133-05-S
• 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	00868201000171 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [Fortera]

• 00868201000188: Calcium compound bone void filler (10 cc)
• 00868201000171: Calcium compound bone void filler (5 cc)
• 00868201000164: Calcium compound bone void filler (3 cc)