NA

Basic Information

• Brand Name: NA
• Primary DI: 10849771050565
• Version / Model: K-Wire and Pin Covers
• Catalog Number: C045
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-10-03
• Public Version: 2
• Public Version Date: 2025-10-16
• Public Version Status: Update
• Public Device Record Key: 519e6b56-0182-4a79-b312-6db41f9d55bb
• Distribution End Date: 2025-09-19

Device Description

K-Wire Covers, Sterile, White,

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50849771050563	GS1	Box	12	Not in Commercial Distribution	2025-09-19
Primary	10849771050565	GS1
Unit of Use	00849771050568	GS1
Previous	00849771004165	GS1

Customer Contacts

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