Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867406445
• Version / Model: AR-9540-17RCA
• Catalog Number: AR-9540-17RCA
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-29
• Public Version: 1
• Public Version Date: 2024-04-08
• Public Version Status: New
• Public Device Record Key: e57f422d-2e2f-4a03-8649-339702cb6daa

Device Description

Revers CA Humeral Head, 40/17

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: MR Conditional
• 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
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61004	Shoulder reverse/standard adaptor prosthesis	A sterile implantable component of a total shoulder prosthesis intended to be used in the revision surgery of a reverse shoulder prosthesis to avoid replacement of the humeral body/stem by enabling articulation between a reverse shoulder body and a standard humeral head [typically a cuff tear arthropathy (CTA) head]. It is a double male taper made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)] and is used in a modular shoulder replacement system.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867406445	GS1

Customer Contacts

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