osteoSPAN 190-SLF

GUDID 00812593020613

9x6x40mm osteoSPAN Blocks

BIOGENNIX LLC

Synthetic bone graft

• Primary Device ID: 00812593020613
• NIH Device Record Key: a1383adb-872b-4b07-89bc-3e012fa00723
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osteoSPAN
• Version Model Number: 190-SLF
• Catalog Number: 190-SLF
• 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 Dimensions

• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter
• Length: 40 Millimeter
• Height: 6 Millimeter
• Width: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020613 [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