Key Surgical K-Wire and Pin Covers

Basic Information

• Brand Name: Key Surgical K-Wire and Pin Covers
• Primary DI: 00849771003717
• Version / Model: C-078
• Catalog Number: C078
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 4
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 36606934-e762-437c-b890-f1598b45b7bf
• Distribution End Date: 2023-05-08

Device Description

Pin Covers, Sterile, Pink, .078-inch, 2.0mm, 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	10849771003714	GS1	Box	12	Not in Commercial Distribution	2023-05-08
Primary	00849771003717	GS1
Unit of Use	00849771043669	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	.078	Inch