ossFX Moldable

GUDID 00812593021641

ossFX Moldable 6cc

Biogennix, LLC

Synthetic bone graft

• Primary Device ID: 00812593021641
• NIH Device Record Key: c16cbaa0-d255-4765-8843-e0c62e5717a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ossFX Moldable
• Version Model Number: AXB-OSS-06
• 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	00812593021641 [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