ACUFEX DIRECTOR

Basic Information

• Brand Name: ACUFEX DIRECTOR
• Primary DI: 03596010000224
• Version / Model: 3134263
• Catalog Number: 3134263
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-12
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 7597a7e5-13ef-4a82-b2c6-28216a5dcc9d

Device Description

MTO BULL ASSY FOUR PNT DIR.ACL GDE

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBH	ACCESSORIES,ARTHROSCOPIC	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47900	Orthopaedic implant calibration pin	A cylindrical rod used preoperatively as a precision guide to align an orthopaedic implant aiming arm with, e.g., an intramedullary bone nail (femoral, humeral, and tibial) that will be implanted. It is inserted through the guiding locking holes of the adjustable aiming arm and its profiled distal tip is engaged into the locking holes of the intramedullary nail providing a given reference point whereby the drill guides and the rest of the aiming arm can be correctly set to correspond with the holes and measurements of the implant. It is typically made of high-grade stainless steel or synthetic materials. Several calibration pins will be used for this procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010000224	GS1

Customer Contacts

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