SMR Shoulder

Basic Information

• Brand Name: SMR Shoulder
• Primary DI: 08033390119443
• Version / Model: Trial Glenoid 3 Pegs
• Catalog Number: 9013.79.031
• Company Name: LIMACORPORATE SPA
• Labeler DUNS: 432066322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-10
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 63e62526-c78a-499d-a451-ebc7719779d6

Device Description

Trial Glenoid 3 Pegs #LARGE - SMR Shoulder

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
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60932	Shoulder glenoid fossa prosthesis trial	A copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and 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	08033390119443	GS1

Premarket Submissions

Submission Number	Supplement Number
K153722	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			#LARGE