Piccolo Composite Plate System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: Piccolo Composite Plate System FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Device Name: Drill Bit for use with the Piccolo Composite Diaphyseal Plate System FDA UDI
Model / Reference: Drill Bit FDA UDI
Description: Drill Bit for use with the Piccolo Composite Diaphyseal Plate System FDA UDI

Identifiers

Catalog Number: PL943125 FDA UDI
Primary DI / UDI-DI: 07290109338668 FDA UDI
510(k) Number: K102597 FDA UDI
K130061 FDA UDI
FDA Product Code: HWC FDA UDI
KTT FDA UDI
HRS FDA UDI
GMDN Term: Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 125 Millimeter FDA UDI
Outer Diameter — 4.3 Millimeter FDA UDI

Category: Fluted surgical drill bit, single-use

Piccolo Composite Plate 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 fa70cb0e-2c59-46f8-bd3d-4406c599d123 37 fields · synced May 30, 2026