Threaded K-Wire,Ø3.2x390mm (3-Pack), PPS

Basic Information

• Brand Name: Threaded K-Wire,Ø3.2x390mm (3-Pack), PPS
• Primary DI: 09120116974000
• Version / Model: 1F0I015A-S
• Catalog Number: 1F0I015A-S
• Company Name: I.T.S. GmbH
• Labeler DUNS: 303456917
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-02
• Public Version: 3
• Public Version Date: 2024-10-04
• Public Version Status: Update
• Public Device Record Key: d726b857-11e3-41a2-a5ef-e0e77b1e72cf

Device Description

Threaded K-Wire,Ø3.2x390mm (3-Pack), PPS

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) 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	09120116974000	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep out of sunlight