Apollo TMS Therapy System

GUDID 04260526050019

MAG & More GmbH

Magnetic neural stimulation system

• Primary Device ID: 04260526050019
• NIH Device Record Key: c02a3332-52c5-4cfe-a9bb-9e370951b018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo TMS Therapy System
• Version Model Number: 918001
• Company DUNS: 328246368
• Company Name: MAG & More 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: true
• 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	04260526050019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180313

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

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: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by MAG & More GmbH

• 04260526050101 - Apollo Light TMS Therapy System: 2024-08-29
• 04260526050019 - Apollo TMS Therapy System: 2023-06-01
• 04260526050019 - Apollo TMS Therapy System: 2023-06-01