Battery for Optune GIO IBH9100US

GUDID 07290107986380

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107986380
NIH Device Record Key2e685718-7fee-44a6-a74e-dcc3e4e2f0dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBattery for Optune GIO
Version Model NumberIBH9100
Catalog NumberIBH9100US
Company DUNS486647295
Company NameNovocure GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107986380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-14
Device Publish Date2025-03-06

On-Brand Devices [Battery for Optune GIO]

07290107983280IBH9100
07290107983273IBH9100
07290107983266IBH9100
07290107986380IBH9100
07290107986236IBH9100

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.