Cortical Drill

FDA UDI

Class I (US FDA UDI)

by Orthopedic Designs North America, Inc.

Identity

Trade Name: Cortical Drill FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: Cortical Drill, 3.4mm FDA UDI
Model / Reference: ODIT109 FDA UDI
Description: Cortical Drill, 3.4mm FDA UDI

Identifiers

Catalog Number: ODI-T109 FDA UDI
Primary DI / UDI-DI: B058ODIT1091 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

Cortical Drill by Orthopedic Designs North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Orthopedic Designs North America, Inc.

Sources (1)

FDA UDI 5f6a9615-6a79-4195-ba5e-128dc00c51f7 35 fields · synced Jun 1, 2026