Fusion Biologics CD-BP-0008-S

GUDID 00840124515123

Bone Plunger 8mm (Sterile)

FUSION ORTHOPEDICS, LLC

Orthopaedic graft inserter, single-use

• Primary Device ID: 00840124515123
• NIH Device Record Key: 53f9542f-56ca-4001-b610-45d85de15f29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Biologics
• Version Model Number: CD-BP-0008-S
• Catalog Number: CD-BP-0008-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• 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	00840124515123 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [Fusion Biologics]

• 00840124518711: OsteoEvans Bone Tamp
• 00840124518704: OsteoCotton Bone Tamp
• 00840124518698: OsteoEvan Sizer 12mm
• 00840124518681: OsteoEvan Sizer 10mm
• 00840124518674: OsteoEvan Sizer 8mm
• 00840124518667: OsteoEvan Sizer 6mm
• 00840124518650: OsteoCotton Sizer 8mm
• 00840124518643: OsteoCotton Sizer 7mm
• 00840124518636: OsteoCotton Sizer 6mm
• 00840124518629: OsteoCotton Sizer 5mm
• 00840124515321: Bone Harvester Kit 12mm
• 00840124515314: Bone Harvester Kit 10mm
• 00840124515307: Bone Harvester Kit 8mm
• 00840124515291: Bone Harvester Kit 7mm
• 00840124515284: Bone Harvester Kit 6mm
• 00840124515147: Bone Plunger 12mm (Sterile)
• 00840124515130: Bone Plunger 10mm (Sterile)
• 00840124515123: Bone Plunger 8mm (Sterile)
• 00840124515116: Bone Plunger 7mm (Sterile)
• 00840124515109: Bone Plunger 6mm (Sterile)
• 00840124515093: Bone Harvester 12mm (Sterile)
• 00840124515086: Bone Harvester 10mm (Sterile)
• 00840124515079: Bone Harvester 8mm (Sterile)
• 00840124515062: Bone Harvester 7mm (Sterile)
• 00840124515055: Bone Harvester 6mm (Sterile)