INE Transducer Array Black Connector INE9000

GUDID 07290107981781

INTEGRA BIOTECHNICAL LLC

Alternating electric field antimitotic cancer treatment system transducer array

• Primary Device ID: 07290107981781
• NIH Device Record Key: ddf1f14f-f0b4-4210-ac0b-353d81a7e149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INE Transducer Array Black Connector
• Version Model Number: INE9000
• Catalog Number: INE9000
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290000000008 [Primary]
GS1	07290107981781 [Package]; Contains: 07290107983402; Package: Carton Box [20 Units]; In Commercial Distribution
GS1	07290107983402 [Primary]

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

[07290107981781]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-13
• Device Publish Date: 2015-09-20

Devices Manufactured by INTEGRA BIOTECHNICAL LLC

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• 07290107982719 - ILE Transducer Arrays Large White Connector: 2020-12-17
• 07290107982726 - ILE Transducer Arrays Large White Connector: 2020-12-17
• 07290107982696 - ILE Transducer Arrays Small Black Connector: 2020-12-16
• 07290107983396 - INE Transducer Arrays White Connector: 2019-05-13
• 07290107981781 - INE Transducer Array Black Connector: 2019-05-13
• 07290107981781 - INE Transducer Array Black Connector: 2019-05-13
• 07290000000007 - INE Transducer Arrays White Connector: 2018-07-06