FuzeRight FR-KW-416

GUDID 00840124505117

K-Wire 1.6mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone wire

• Primary Device ID: 00840124505117
• NIH Device Record Key: 9c57ca7d-8435-4699-b719-947c41662ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeRight
• Version Model Number: FR-KW-416
• Catalog Number: FR-KW-416
• 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: 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	00840124505117 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

[00840124505117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-22
• Device Publish Date: 2021-04-14

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
• 00840124514843: Implant Kit (Sterile)