ACUFEX

Basic Information

• Brand Name: ACUFEX
• Primary DI: 03596010388254
• Version / Model: 7207284
• Catalog Number: 7207284
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 8
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: f1cee90c-cbcb-4bda-bc94-c5781827bd95

Device Description

PCL SAFETY GUIDE WIRE REQUIRED CALIBRATED GUIDE WIRE USED IN CONJUNCTION WITH THE ACUFEX DIRECTOR PCL SAFETY STOP TO INDICATE WHEN THE TIP OF THE WIRE HAS PENETRATED THE POSTERIOR CORTEX

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010388254	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]