NovoTAL flex SW000128

GUDID 07290107984447

Novocure GmbH

Alternating electric field antimitotic cancer treatment system

• Primary Device ID: 07290107984447
• NIH Device Record Key: dd92e4ca-75bb-4876-becb-0e922962c394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoTAL flex
• Version Model Number: SW000128
• Catalog Number: SW000128
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107984447 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-13
• Device Publish Date: 2024-11-05

Devices Manufactured by Novocure GmbH

• 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
• 07290107986380 - Battery for Optune GIO: 2025-03-14
• 07290107986397 - Optune Gio Battery Charger: 2025-03-14
• 07290107986403 - Power Supply for Optune Gio: 2025-03-14
• 07290107986427 - Optune Gio: 2025-03-14
• 07290107984447 - NovoTAL flex: 2024-11-13
• 07290107984447 - NovoTAL flex: 2024-11-13