ZEUS

Basic Information

• Brand Name: ZEUS
• Primary DI: 05904569152208
• Version / Model: Zeus V1
• Catalog Number: A-01-L
• Company Name: AETHER BIOMEDICAL SP Z O O
• Labeler DUNS: 850705379
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-15
• Public Version: 2
• Public Version Date: 2023-08-17
• Public Version Status: Update
• Public Device Record Key: 202ab743-b835-4903-a562-7c4d0df0b430

Device Description

ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand intended to be used with other appropriate upper limb components to form a complete arm prosthesis, to be fitted only by qualified and certified clinicians. It should be used only by upper limb (forearm). Zeus V1 is suitable for 3 amputation levels: below-elbow, above-elbow and shoulder

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQZ	Hand, External Limb Component, Powered	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41082	Electrical hand prosthesis	An artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. The control of the motor is through an electromechanical switch operated by body movement using straps or cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05904569152215	GS1	box	1	In Commercial Distribution
Primary	05904569152208	GS1