ILE Transducer Arrays Small White Connector ILE9010WUS

GUDID 07290107982702

INTEGRA BIOTECHNICAL LLC

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• Primary Device ID: 07290107982702
• NIH Device Record Key: 8004e944-dc65-406e-9f4f-f41855082381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILE Transducer Arrays Small White Connector
• Version Model Number: ILE1010W
• Catalog Number: ILE9010WUS
• Company DUNS: 079342722
• Company Name: INTEGRA BIOTECHNICAL LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *WEEE

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107982702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H180002

FDA Product Code

• QGZ: Electrical Tumor Treatment Fields

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-17
• Device Publish Date: 2020-12-09

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