osteoSPAN 100-30G

GUDID 00812593020620

1-4mm osteoSPAN Granules

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

• Primary Device ID: 00812593020620
• NIH Device Record Key: cd747b19-b69d-41b2-a4fc-3481f2b927af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osteoSPAN
• Version Model Number: 100-30G
• Catalog Number: 100-30G
• Company DUNS: 021486533
• 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	00812593020620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093342

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-19

On-Brand Devices [osteoSPAN]

• 00812593020620: 1-4mm osteoSPAN Granules
• 00812593020613: 9x6x40mm osteoSPAN Blocks
• 00812593020606: 6x6x40mm osteoSPAN Blocks