SigmaStim Sigma

Primary DI
00850045508012
Brand
SigmaStim Sigma
Company
SIGMASTIM DOMESTIC, LLC
Model
9438-5001
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar DisorderNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192834000MECTA SigmaMecta Corporation2020-04-26QGH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045508012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045508012008500455080128500455080120850045508012

GMDN Terms#

Term, Definition table
TermDefinition
Electroconvulsive therapy systemAn assembly of mains electricity (AC-powered) devices designed to apply strong electrical stimuli (electric shocks) to a patient's brain to induce convulsions (fit or grand mal seizure of the brain) and loss of consciousness, typically to treat major depression, schizophrenia, or mania. The stimuli are applied through electrodes placed on the unshaved scalp or on the bare skin over the temples; they are not usually targeted toward specific areas of the brain. The system typically consists of an operator's console with controls, displays and printers, and electrodes; it may also include monitors (e.g., electrocardiograph, electroencephalograph) to display vital signs during treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111226730
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850045508071Cotton Bite Block9391-0003 L2025-01-27
10850045508088Cotton Bite Block9391-0003 M2025-01-27