SMR System

Basic Information

• Brand Name: SMR System
• Primary DI: 08033390002233
• Version / Model: 1362.09.010
• Catalog Number: 1362.09.010
• Company Name: LIMACORPORATE SPA
• Labeler DUNS: 432066322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: 183ca6e6-372d-4313-993a-5f171e63e0f3

Device Description

SMR System - Reverse HP Liner Short Dia. 44mm

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
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	888.3660	2
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	888.3670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60514	Metallic reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a metal cup intended to be attached to either a humeral stem prosthesis or humeral body component, and to articulate with the reverse shoulder head.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033390002233	GS1

Premarket Submissions

Submission Number	Supplement Number
K252352	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Short Dia. 44mm