INTERFACE IFBG100

GUDID 00816986020037

INTERFACE is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass (45S5 Bioglass), sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed.

BIOVENTUS LLC

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• Primary Device ID: 00816986020037
• NIH Device Record Key: 8b86d02c-3c78-48da-b8eb-fb5dbc4bb8a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERFACE
• Version Model Number: IFBG100
• Catalog Number: IFBG100
• Company DUNS: 078450878
• Company Name: BIOVENTUS 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

Customer Support Contacts

• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com

Device Dimensions

• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816986020037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112857

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: 2019-05-14
• Device Publish Date: 2019-05-06

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