Thymatron IV

Basic Information

• Brand Name: Thymatron IV
• Primary DI: 00850298007003
• Version / Model: System IV
• Catalog Number: EDIV
• Company Name: SOMATICS, LLC
• Labeler DUNS: 187194337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 1
• Public Version Date: 2018-09-24
• Public Version Status: New
• Public Device Record Key: 95c5623a-85fe-45ca-9b63-d6cadb1bcad0

Device Description

Electroconvulsive Therapy Instrument

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXC	Device, Electroconvulsive Therapy	Neurology	882.5940	3

GMDN Terms

Code	Name	Definition	Implantable	Status
63214	Electroporation therapy system generator	A mains electricity (AC-powered) non-patient-contact component of an electroporation therapy system intended to generate electrical impulses to be used for electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)] and genetic materials [electrogenetherapy (EGT)], to reach the cytoplasm. It is a computerized current generator with controls intended to be used with appropriate probes/handpieces/electrodes (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850298007003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	22	Pound
Depth	5.25	Inch
Height	13	Inch
Width	18	Inch