ossFX Moldable

GUDID 00812593021634

ossFX Moldable 3cc

Biogennix, LLC

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 00812593021634
• NIH Device Record Key: 3fa1ddb2-b4f2-4dca-8715-4ef43bf2daa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ossFX Moldable
• Version Model Number: AXB-OSS-03
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593021634 [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: 2023-12-21
• Device Publish Date: 2023-12-13

On-Brand Devices [ossFX Moldable]

• 00812593021658: ossFX Moldable 12cc
• 00812593021641: ossFX Moldable 6cc
• 00812593021634: ossFX Moldable 3cc
• 00812593021627: ossFX Moldable 1.5cc