FuzeFix Twist Off

GUDID 00819034021840

Twist Off Driver Breakaway Driver 2.0mm

FUSION ORTHOPEDICS, LLC

Surgical screwdriver, reusable

• Primary Device ID: 00819034021840
• NIH Device Record Key: 86adb9b2-c8aa-470b-bd2a-5e8cdd5af990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Twist Off
• Version Model Number: CD-TW-3120
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, 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: 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	00819034021840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

[00819034021840]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [FuzeFix Twist Off]

• 00819034023196: TN-FX-8030 Depth Guage
• 00819034021864: Twist Off Driver Stem Driver 2.0mm
• 00819034021857: Twist Off Driver Stem Driver 2.5mm
• 00819034021840: Twist Off Driver Breakaway Driver 2.0mm
• 00819034021833: Twist Off Driver Breakaway Driver 2.5mm