Key Surgical K-Wire and Pin Covers

Basic Information

• Brand Name: Key Surgical K-Wire and Pin Covers
• Primary DI: 00849771004196
• Version / Model: C-035
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 3
• Public Version Date: 2021-09-08
• Public Version Status: Update
• Public Device Record Key: 48224cea-459f-4b57-bb53-e976ca30619d

Device Description

K-Wire Covers, Sterile, Blue, .035" / 0.9mm, 2/pkg

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
46505	Surgical instrument guard, single-use, sterile	A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849771004193	GS1	Box	12	In Commercial Distribution
Primary	00849771004196	GS1
Unit of Use	00849771043584	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	.035	Inch