R3

Basic Information

• Brand Name: R3
• Primary DI: 00885556028056
• Version / Model: 71369859
• Catalog Number: 71369859
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 8
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 4904abf2-80b9-4a80-a1b5-bf748e3e3405

Device Description

R3 20+4 28ID DISPOSABLE TRIAL LINER 46MMOD

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDG	Prosthesis, hip, femoral component, cemented, metal	Orthopedic	888.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58480	Acetabulum prosthesis trial, prefabricated, reusable	A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. 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
Package	20885556028050	GS1	BX	3	In Commercial Distribution
Primary	00885556028056	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123598	000