SigmaStim Sigma

GUDID 00850045508012

SIGMASTIM DOMESTIC, LLC

Electroconvulsive therapy system

• Primary Device ID: 00850045508012
• NIH Device Record Key: 314fc567-1657-48a6-a87e-e2964ca61829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SigmaStim Sigma
• Version Model Number: 9438-5001
• Company DUNS: 111226730
• Company Name: SIGMASTIM DOMESTIC, LLC
• 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	00850045508012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192834

FDA Product Code

• QGH: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar 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: 2025-02-03
• Device Publish Date: 2025-01-24

Devices Manufactured by SIGMASTIM DOMESTIC, LLC

• 10850045508071 - Cotton Bite Block: 2025-02-04 MECTA ECT Cotton Bite Blocks Size Large
• 10850045508088 - Cotton Bite Block: 2025-02-04 MECTA ECT Cotton Bite Blocks Size Medium
• 00850045508012 - SigmaStim Sigma: 2025-02-03
• 00850045508012 - SigmaStim Sigma: 2025-02-03