Piccolo Composite Nailing System / CarboClear Pedi Q9105110

GUDID 07290109338002

Mallet for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankle Arthrodesis Nailing Systems, and with the CarboClear Pedic

CARBOFIX ORTHOPEDICS LTD

Surgical mallet

• Primary Device ID: 07290109338002
• NIH Device Record Key: 91e90bf1-1a96-4fcd-a4f7-dba8a09e2f4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Nailing System / CarboClear Pedi
• Version Model Number: Mallet
• Catalog Number: Q9105110
• 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
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109338002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091425

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07290109338002]

Moist Heat or Steam Sterilization

[07290109338002]

Moist Heat or Steam Sterilization

[07290109338002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-04
• Device Publish Date: 2016-09-18

Devices Manufactured by CARBOFIX ORTHOPEDICS LTD

• 17290117355074 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355081 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355098 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355104 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355111 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355128 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355135 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Solid
• 17290117355272 - CarboClear X Pedicle Screw System: 2025-04-11 CarboClear X Dual Thread Pedicle Screw Fenestrated