Model: GTI-00071
DI: 00850031859098
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Aliya EX Generator
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e9e6c375-4bf1-4bec-8a2f-d27ed9d2a429
Distribution Status:
In Commercial Distribution
DUNS Number:
070000990
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850031859098
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64224
Name: Irreversible electroporation system generator
Definition:
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).
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
OAB
Low Energy Direct Current Thermal Ablation System
Premarket Submissions
Submission Number:
K253826
Supplement Number:
000