ILIZAROV

Basic Information

• Brand Name: ILIZAROV
• Primary DI: 23596010410461
• Version / Model: 71011500
• Catalog Number: 71011500
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2015-08-29
• Public Version: 9
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: 65101cdd-9d10-4cbe-aa60-52797433bfd5

Device Description

1.8MM TITANIUM WIRE SMOOTH BAYONET POINT

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: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
JDW	PIN, FIXATION, THREADED	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66933	Orthopaedic bone cerclage wire	An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	23596010410461	GS1
Unit of Use	03596010410467	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201253	000
K994143	000