PURvital

GUDID 00812593021719

Biogennix, LLC

Synthetic bone graft

• Primary Device ID: 00812593021719
• NIH Device Record Key: c82e9d91-5b8c-476e-b5cc-d141b50d357e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURvital
• Version Model Number: 012-VITAL
• Company DUNS: 832270370
• Company Name: Biogennix, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593021719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190371

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [PURvital]

• 00812593021719: 012-VITAL
• 00812593021702: 006-
• 00812593021696: 003-VITAL
• 00812593021689: 001-VITAL