Key Surgical K-Wire and Pin Covers

Basic Information

• Brand Name: Key Surgical K-Wire and Pin Covers
• Primary DI: 00849771008200
• Version / Model: C-035NS
• Catalog Number: C-035NS
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 5
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: 9287863f-40b3-4914-b8bf-558e0f5458c0
• Distribution End Date: 2023-04-17

Device Description

K-Wire Covers, Non-Sterile, Blue, .035-inch, 0.9mm, Bulk package 50

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: 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: 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
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
Unit of Use	00849771043591	GS1
Primary	00849771008200	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	.035	Inch