Optune Pax TFP9200US

GUDID 07290107987509

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator

• Primary Device ID: 07290107987509
• NIH Device Record Key: 6d5f3969-2aa2-48ef-8d6d-5b3de8d813c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optune Pax
• Version Model Number: TFP9200
• Catalog Number: TFP9200US
• Company DUNS: 486647295
• Company Name: Novocure GmbH
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *WEEE
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 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
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107987509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P250034

FDA Product Code

• SHC: Low Electric Field Generator For Pancreatic Cancer Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-24
• Device Publish Date: 2026-02-16

Devices Manufactured by Novocure GmbH

• 07290107987462 - Connection Cable for Optune Pax: 2026-02-24
• 07290107987479 - Battery for Optune Pax: 2026-02-24
• 07290107987486 - Optune Pax Battery Charger: 2026-02-24
• 07290107987493 - Power Supply for Optune Pax: 2026-02-24
• 07290107987509 - Optune Pax: 2026-02-24
• 07290107987509 - Optune Pax: 2026-02-24
• 07290107985895 - Optune HFE transducer array white: 2025-06-26
• 07290107986236 - Battery for Optune GIO: 2025-03-14
• 07290107986373 - Connection Cable for Optune Gio: 2025-03-14 Connection Cable unit