Optune 90051

GUDID 07290107981682

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system generator

• Primary Device ID: 07290107981682
• NIH Device Record Key: 54a4ea26-bde5-444d-a728-1ef52a1d136b
• Commercial Distribution Discontinuation: 2019-04-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Optune
• Version Model Number: THF9000
• Catalog Number: 90051
• Company DUNS: 056552035
• Company Name: NOVOCURE INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Special Storage Condition, Specify: Between 0 and 0 *WEEE

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107981682 [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: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-24
• Device Publish Date: 2015-09-20

On-Brand Devices [Optune]

• 07290107982207: TFH9100
• 07290107981682: THF9000