Equinoxe

Basic Information

• Brand Name: Equinoxe
• Primary DI: 10885862536655
• Version / Model: 321-40-03
• Catalog Number: 321-40-03
• Company Name: Exactech, Inc.
• Labeler DUNS: 157565946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-19
• Public Version: 1
• Public Version Date: 2022-09-27
• Public Version Status: New
• Public Device Record Key: b5bdbaf9-edfd-44a7-9665-1f52c3f1c527

Device Description

HUMERAL LINER TRIAL 40MM, +2.5

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: Yes
• 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
HWT	TEMPLATE	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60937	Reverse shoulder cup prosthesis trial, reusable	A copy of a final reverse shoulder prosthesis cup 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 intended to connect to a reverse shoulder prosthesis/trial prosthesis body and articulates with a reverse shoulder prosthesis/trial prosthesis head; it is 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	10885862536655	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	40	Millimeter
Height	2.5	Millimeter