Piccolo Composite Systems PFT912220

GUDID 07290110200954

Handle for use with the Piccolo Composite Distal Femur Plate System and Ankle Arthrodesis Nailing System

CARBOFIX ORTHOPEDICS LTD

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 07290110200954
• NIH Device Record Key: 42dc0c53-4c4f-496d-b405-cf4d7f3d503b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Systems
• Version Model Number: Opening Pin
• Catalog Number: PFT912220
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: +97299511511
• Email: info@carbo-fix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110200954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123810

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[07290110200954]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-03-27

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