FuzeRight

GUDID 00840124511125

Peg and Hole Reaming Kit Stainless Steel

FUSION ORTHOPEDICS, LLC

Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00840124511125
• NIH Device Record Key: 7c368fdf-6fbb-488f-9c1a-3bed7e5200bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeRight
• Version Model Number: HT-60-8000-SS
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• 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	00840124511125 [Primary]

FDA Product Code

• HTO: Reamer

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: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [FuzeRight]

• 00840124505117: K-Wire 1.6mm
• 00840124501126: Peg and Hole Reaming Kit
• 00840124502260: Peg and Hole Reaming Kit
• 00840124511125: Peg and Hole Reaming Kit Stainless Steel