AccessGUDID - DEVICE: ZEUS (05904569152239)

GUDID

Device Identifier (DI) Information

Brand Name: ZEUS
Version or Model: Zeus V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A-01-R
Company Name: AETHER BIOMEDICAL SP Z O O

Primary DI Number: 05904569152239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 850705379 *Terms of Use

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. For right hand.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQZ	Hand, External Limb Component, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dbea6be6-ca71-497e-a797-1219e876c016
Public Version Date: August 17, 2023
Public Version Number: 2
DI Record Publish Date: April 19, 2022