CloudTMS Edge for OCD

GUDID 04650075335949

No description

NEUROSOFT, OOO

Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system

• Primary Device ID: 04650075335949
• NIH Device Record Key: 2b3caf7e-d752-4ddf-a4fa-fbf04ea7e135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CloudTMS Edge for OCD
• Version Model Number: Irbis cooling unit
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• 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

Customer Support Contacts

• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075335949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233742

FDA Product Code

• QCI: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

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: 2024-01-22
• Device Publish Date: 2024-01-12

On-Brand Devices [CloudTMS Edge for OCD]

• 04650075335949: No description
• 04650075335895: The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult pat