COFIELD

Basic Information

• Brand Name: COFIELD
• Primary DI: 03596010465726
• Version / Model: 71249626
• Catalog Number: 71249626
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-29
• Public Version: 7
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: ec30cd25-4788-4727-b744-a3a560c93c14
• Distribution End Date: 2020-05-18

Device Description

COFIELD II ECCENTRIC 5MM TRIAL HEAD 26MM X 48MM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
58784	Humeral head prosthesis trial, reusable	A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010465726	GS1

Customer Contacts

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