OSTEOFUSE OF001

GUDID 00816986020082

Bioactive Bone Graft Putty

BIOVENTUS LLC

Bone matrix implant, synthetic Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00816986020082
• NIH Device Record Key: 7d81895d-7eab-4de2-8982-dde812a1dd44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOFUSE
• Version Model Number: 3.75g
• Catalog Number: OF001
• 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

Operating and Storage Conditions

• 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	00816986020082 [Primary]
GS1	00852371006033 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132071

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: 2
• Public Version Date: 2020-03-20
• Device Publish Date: 2019-02-22

On-Brand Devices [OSTEOFUSE]

• 00816986020082: Bioactive Bone Graft Putty
• 00816986020105: Bioactive Bone Graft Putty
• 00816986020099: Bioactive Bone Graft Putty