Acufex

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: ACUFEX FDA UDI
Generic Name: Bone awl, reusable FDA UDI
Device Name: OVAL SIZING TUBE/DILATOR FDA UDI
Model / Reference: 7207292 FDA UDI
Description: OVAL SIZING TUBE/DILATOR FDA UDI

Identifiers

Catalog Number: 7207292 FDA UDI
Primary DI / UDI-DI: 03596010440402 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Bone awl, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone awl, reusable

Acufex by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone awl, reusable.

Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
Navigated Instruments — EVOLUTION SPINE, LLC · Class II
PYRENEES Cervical Plate System — K2M, INC. · Class I
Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
CONMED — Conmed Corporation · Class I
Sklar® — Sklar Corporation · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Zuma-L — SeaSpine Orthopedics Corporation · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 2bd744fa-4890-4636-a265-32f027a8e991 35 fields · synced Jun 8, 2026