ZEUS

GUDID 05905515340021

prosthesis hand

AETHER BIOMEDICAL SP Z O O

Myoelectric hand prosthesis
Primary Device ID05905515340021
NIH Device Record Key862820ee-7758-4e46-9c40-c03cd945c872
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEUS
Version Model NumberA-01-R-T
Company DUNS850705379
Company NameAETHER BIOMEDICAL SP Z O O
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105905515340014 [Primary]
GS105905515340021 [Package]
Contains: 05905515340014
Package: box [1 Units]
In Commercial Distribution

FDA Product Code

IQZHand, External Limb Component, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-27
Device Publish Date2023-03-19

On-Brand Devices [ZEUS]

05904569152215ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand inten
05904569152246ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand inten
05905515340021prosthesis hand
05905515340007A-01-L-T

Trademark Results [ZEUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZEUS
ZEUS
98613822 not registered Live/Pending
Mando International Llc
2024-06-22
ZEUS
ZEUS
98563480 not registered Live/Pending
Leland S. Berliner
2024-05-22
ZEUS
ZEUS
98473702 not registered Live/Pending
HALEU Energy Fuel Inc.
2024-03-28
ZEUS
ZEUS
98372627 not registered Live/Pending
VAV PLASTICS, INC.
2024-01-24
ZEUS
ZEUS
98364119 not registered Live/Pending
Palmetto State Armory, LLC
2024-01-18
ZEUS
ZEUS
98277766 not registered Live/Pending
Remco Industries
2023-11-20
ZEUS
ZEUS
98233307 not registered Live/Pending
Palm Beach Beaute, LLC
2023-10-20
ZEUS
ZEUS
98155390 not registered Live/Pending
Atlas 21, Inc.
2023-08-29
ZEUS
ZEUS
98103036 not registered Live/Pending
Bolt Graphics, Inc.
2023-07-26
ZEUS
ZEUS
98096161 not registered Live/Pending
Arco Holding Company, Inc.
2023-07-21
ZEUS
ZEUS
98061788 not registered Live/Pending
World Wrestling Entertainment, Inc.
2023-06-27
ZEUS
ZEUS
97660306 not registered Live/Pending
GROOVE LIFE CORPORATION
2022-11-02

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