LIGAFIX

Basic Information

• Brand Name: LIGAFIX
• Primary DI: 03760154002592
• Version / Model: Rigid guide pin X10
• Catalog Number: LIG9114300-10
• Company Name: S.B.M
• Labeler DUNS: 772462123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 2
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: 1de8d834-fb48-46bc-8ea0-d1f88c599447

Device Description

Rigid guide pin Ø 1.4 mm - L 300 mm to be used with LIGAFIX screwdriver for interference screws of diameter 9, 10 and 11 mm in ACL reconstruction. 10 units per package

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: Yes
• 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
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) 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	03760154002592	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.4	Millimeter
Length	300	Millimeter