Aliya Generator

Basic Information

• Brand Name: Aliya Generator
• Primary DI: 00850031859050
• Version / Model: GTI-00017
• Company Name: Galvanize Therapeutics, Inc.
• Labeler DUNS: 070000990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-18
• Public Version: 1
• Public Version Date: 2023-08-28
• Public Version Status: New
• Public Device Record Key: 3aa163cf-1527-49b1-97d7-9e89013971cc

Device Description

Aliya Generator, 2.5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64224	Irreversible electroporation system generator	A mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. It includes controls (e.g., foot-switch) and user interface; additional system components necessary for the procedure [e.g., electrocardiogram (ECG) trigger monitor electrode probe/catheter] are not included. It is intended for the nonthermal surgical ablation of soft-tissues and may be intended for one or more clinical application(s).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850031859050	GS1

Premarket Submissions

Submission Number	Supplement Number
K212871	000