ACUFEX

Basic Information

• Brand Name: ACUFEX
• Primary DI: 03596010032607
• Version / Model: 010600
• Catalog Number: 010600
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 6
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 048b070a-492f-4ede-8ec4-c5a4a9a34645

Device Description

DISPOSABLE KNIFE HOOK STRAIGHT 3.0 MM BOX OF 5

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
NBH	ACCESSORIES,ARTHROSCOPIC	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45169	Stereotactic surgery system probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	23596010032601	GS1	BX	5	In Commercial Distribution
Primary	03596010032607	GS1

Customer Contacts

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