ThunderCell Battery

GUDID 08057971590636

ThunderCell Battery, white (device)

BIONIT LABS SRL

Secondary battery
Primary Device ID08057971590636
NIH Device Record Key5f01c2f6-aefa-4dac-8b65-1c8e7db6f41c
Commercial Distribution StatusIn Commercial Distribution
Brand NameThunderCell Battery
Version Model NumberEB02-W
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 Datefalse
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108057971590636 [Package]
Contains: 08057971592722
Package: Box [1 Units]
In Commercial Distribution
GS108057971590667 [Package]
Contains: 08057971592722
Package: Box [2 Units]
In Commercial Distribution
GS108057971592722 [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 Date2024-08-19
Device Publish Date2024-08-09

On-Brand Devices [ThunderCell Battery]

08057971592715ThunderCell Battery, beige (device)
08057971590636ThunderCell Battery, white (device)
08057971590612ThunderCell Battery, black (device)

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