NA

Basic Information

• Brand Name: NA
• Primary DI: 10849771050404
• Version / Model: K-Wire and Pin Covers
• Catalog Number: C028
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: 9aa60476-1fea-47e1-af8c-119bfa2846d7

Device Description

K-Wire Covers, Sterile, Yellow, .028-inch inner diameter, 0.7mm, 2 per package

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	50849771050402	GS1	Box	12	In Commercial Distribution
Primary	10849771050404	GS1
Unit of Use	00849771050407	GS1
Previous	00849771004226	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.028	Inch