Modular Radial Head (MRH) System

Basic Information

• Brand Name: Modular Radial Head (MRH) System
• Primary DI: 00885556857571
• Version / Model: TRL-352-22L
• Catalog Number: TRL-352-22L
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-22
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 9161b480-8564-4358-be75-76efc9bf5006

Device Description

MRH HEAD TRIAL SZ. 22L

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: No
• 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
KWI	PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER	Orthopedic	888.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61212	Elbow radius prosthesis trial	A copy of a final elbow radius prosthesis designed to be used for trial reductions during elbow arthroplasty to help determine the correct size, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and 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	00885556857571	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032686	000