Piccolo Composite Plate System

Basic Information

• Brand Name: Piccolo Composite Plate System
• Primary DI: 07290109339757
• Version / Model: Targeting Guide - Narrow Left
• Catalog Number: PLL92100
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-18
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5699ea0d-9773-4b76-90e6-f4d73f94615a

Device Description

Targeting Guide for use with the Piccolo Composite Distal Radius Plate System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	888.3030	2
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47815	Orthopaedic implant aiming/guiding block, reusable	A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109339757	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102597	000