Piccolo Composite Nailing System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: Piccolo Composite Nailing System FDA UDI
Generic Name: Manual wire driver FDA UDI
Device Name: Guide Wire Holder for use with the Piccolo Composite Tibia, Femur, and Proximal Femur Nailing Systems. FDA UDI
Model / Reference: Guide Wire Holder FDA UDI
Description: Guide Wire Holder for use with the Piccolo Composite Tibia, Femur, and Proximal Femur Nailing Systems. FDA UDI

Identifiers

Catalog Number: PFT912340 FDA UDI
Primary DI / UDI-DI: 07290109338224 FDA UDI
510(k) Number: K102369 FDA UDI
K111056 FDA UDI
K151010 FDA UDI
K153536 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Manual wire driver FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual wire driver

Piccolo Composite Nailing System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI f605b102-aa60-4129-ba10-f98f9d80930d 36 fields · synced May 30, 2026