INE Transducer Arrays Tan Plaster and Black Connector INE9020US

GUDID 07290107983310

Novocure GmbH

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• Primary Device ID: 07290107983310
• NIH Device Record Key: 26fc20f4-3d60-4890-b65e-5b1b37964ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INE Transducer Arrays Tan Plaster and Black Connector
• Version Model Number: INE9TAN
• Catalog Number: INE9020US
• Company DUNS: 486647295
• Company Name: Novocure GmbH
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107983310 [Primary]
GS1	07290107984874 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100034

FDA Product Code

• NZK: Stimulator, Low Electric Field, Tumor Treatment

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

[07290107983310]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-10
• Device Publish Date: 2020-08-19

On-Brand Devices [INE Transducer Arrays Tan Plaster and Black Connector]

• 07290107983839: INE9TAN
• 07290107983310: INE9TAN