Threaded Pin - 3.2mm x 150mm – x5

Basic Information

• Brand Name: Threaded Pin - 3.2mm x 150mm – x5
• Primary DI: 09421038411353
• Version / Model: 5000-2013-5
• Catalog Number: 5000-2013-5
• Company Name: ENZTEC LIMITED
• Labeler DUNS: 592616445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-10-07
• Public Version: 1
• Public Version Date: 2025-10-15
• Public Version Status: New
• Public Device Record Key: d6877f61-4bd0-4d76-aed5-c958fa459a50

Device Description

A single use surgical instrument intended to be used during an orthopaedic surgical procedure

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66935	Orthopaedic intraoperative positioning pin, single-use	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	09421038411322	GS1
Primary	09421038411353	GS1