Shoulder iD

Basic Information

• Brand Name: Shoulder iD
• Primary DI: 00840338604224
• Version / Model: DWJ609
• Catalog Number: DWJ609
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: f4aea75a-d354-4b4b-ae29-dcf73c25789d

Device Description

Primary Reversed Glenoid

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48091	Reverse shoulder prosthesis base plate	A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840338604224	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	25	Millimeter
Device Size Text, specify			+3mm Offset
Length	35	Millimeter