INE Transducer Arrays White Connector INE9000W

GUDID 07290107983396

INTEGRA BIOTECHNICAL LLC

Alternating electric field antimitotic cancer treatment system transducer array

• Primary Device ID: 07290107983396
• NIH Device Record Key: d13a4e34-67b7-4a4a-a40e-8316c1180a6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INE Transducer Arrays White Connector
• Version Model Number: INE9000W
• Catalog Number: INE9000W
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107981798 [Package]; Package: Carton Box [20 Units]; In Commercial Distribution
GS1	07290107983396 [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

[07290107983396]

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

On-Brand Devices [INE Transducer Arrays White Connector]

• 07290000000007: INE9000W
• 07290107983396: INE9000W