Adam's Hand

GUDID 08057971590018

Adam's Hand - Left, Medium, Black

BIONIT LABS SRL

Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis
Primary Device ID08057971590018
NIH Device Record Key28e75fdc-ff9d-45b0-ac29-22df6fcc8e02
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdam's Hand
Version Model NumberAH02-LM1-B1
Company DUNS439080477
Company NameBIONIT LABS SRL
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com
Phone+3908361946903
Emailsupport@bionitlabs.com

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108057971590018 [Primary]

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 Date2024-04-24
Device Publish Date2024-04-16