Piccolo Composite Nailing System PPF910470

GUDID 07290109338064

Drill Bit for use with the Piccolo Composite Proximal Femur Nailing System

CARBOFIX ORTHOPEDICS LTD

Cannulated surgical drill bit, single-use, sterile

• Primary Device ID: 07290109338064
• NIH Device Record Key: f9eb595b-cc92-4cd7-9757-9f8f87602d61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Nailing System
• Version Model Number: Lag Screw Step Drill Bit
• Catalog Number: PPF910470
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com
• Phone: +97299511511
• Email: info@carbo-fix.com

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 425 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.3 Millimeter
• Length: 490 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109338064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151010

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-18

On-Brand Devices [Piccolo Composite Nailing System]

• 07290110204389: Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteri
• 07290110202415: Cortical screw for use with tibia, femur, ankle arthrodesis nails
• 07290110202194: Sterilization case for use with the Piccolo Composite Humeral Nailing Systems
• 07290110202187: Cortical screw for use with humerus nails
• 07290110202170: Cortical screw for use with humerus nails
• 07290110202163: Cortical screw for use with humerus nails
• 07290110202156: Cortical screw for use with humerus nails
• 07290110202149: Cortical screw for use with humerus nails
• 07290110202132: Cortical screw for use with humerus nails
• 07290110202118: Drill Bit for use with the Piccolo Composite Humeral Nailing System
• 07290110202101: Sleeve for use with the Piccolo Composite Humeral Nailing Systems.
• 07290110202095: Sleeve for use with the Piccolo Composite Humeral Nailing Systems.
• 07290110202088: Proximal humerus nail indicated for simple fractures; severely comminuted, spiral, large oblique
• 07290110202071: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110202064: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110202057: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110202040: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110202033: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110202026: Humeral nail indicated for simple fractures; severely comminuted, spiral, large oblique and segm
• 07290110201746: Drill Bit for use with the Piccolo Composite Humeral Nailing System
• 07290110201739: Cortical screw for use with humerus nails
• 07290110201555: Lag screw for use with proximal femur nails.
• 07290110201548: Lag screw for use with proximal femur nails.
• 07290110201531: Lag screw for use with proximal femur nails.
• 07290110201524: Lag screw for use with proximal femur nails.
• 07290110201517: Lag screw for use with proximal femur nails.
• 07290110201500: Lag screw for use with proximal femur nails.
• 07290110201494: Lag screw for use with proximal femur nails.
• 07290110200985: An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
• 07290110200978: An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
• 07290110200961: An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indica
• 07290110200947: Screwdriver for use with the Piccolo Composite Ankle Arthrodesis Nailing System.
• 07290110200930: Wrench for use with the Piccolo Composite Ankle Arthrodesis Nailing System
• 07290110200923: Drill Bit for use with the Piccolo Composite Ankle Arthrodesis Nailing System
• 07290110200909: Depth Gauge for use with the Piccolo Composite Ankle Arthrodesis Nailing System
• 07290110200893: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200886: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200879: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200862: Connects the Piccolo Composite Ankle Arthrodesis Nailing System Handle to the Nail.
• 07290110200855: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200848: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200831: Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
• 07290110200824: Handle for use with the Piccolo Composite Ankle Arthrodesis Nailing System
• 07290110200817: Sterilization case for use with the Piccolo Composite Ankle Arthrodesis Nailing System.
• 07290110200756: Unified set screw; part of the Piccolo Composite proximal femur nail.
• 07290110200633: Sterilization case for use with the Piccolo Composite Tibia Nailing System.
• 07290110200619: Awl for use with the Piccolo Composite Tibia Nailing System.
• 07290110200602: Adapter for use with the Piccolo Composite Tibia Nailing System.
• 07290110200589: Instrumentation handle for use with the Piccolo Composite Tibia Nailing System.
• 07290110200572: Trocar for use with the Piccolo Composite Tibia Nailing System.