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FO NX Nail System

FDA UDI

Class I (US FDA UDI)

by Field Orthopaedics Pty Ltd

Identity

Trade Name
FO NX Nail System FDA UDI
Generic Name
Cannulated surgical drill bit, single-use, non-sterile FDA UDI
Device Name
3.5 Metaphyseal Cannulated Hand Drill 1/pkg FDA UDI
Model / Reference
APN000262 FDA UDI
Description
3.5 Metaphyseal Cannulated Hand Drill 1/pkg FDA UDI

Identifiers

Catalog Number
NXMD(c)-35/1 FDA UDI
Primary DI / UDI-DI
09353903009023 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use, non-sterile 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, single-use, non-sterile

FO NX Nail System by Field Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Field Orthopaedics Pty Ltd

Sources (1)

  • FDA UDI b6078443-0647-4c14-a782-aca7c4f12b3e 34 fields · synced Jun 8, 2026