Model: GTI-00024
DI: 00850031859029
Status: Update
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2024-02-21
Current Version: 2026-05-15
Description
Aliya Electrode, 5 pack
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
3
Record Key:
472a4db7-c3bf-428e-8175-ef9f71e0e67e
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:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00850031859029
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Box
Item #2 - Device ID:
10850031859026
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
5
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00850031859029
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 67086
Name: Irreversible electroporation system probe connection electrode
Definition:
A slender electrical conductor with a connection cable intended to be inserted within the lumen of an irreversible electroporation system probe (i.e., a percutaneous and/or endoscopic probe) to deliver short electrical pulses, in a monopolar configuration, from a system generator to the probe to produce irreversible cell membrane electroporation, for ablation of soft tissue (excludes cardiac tissue). The device does not have direct contact with tissues (i.e., it is not a probe). This is a single-use device.
FDA Product Codes
OAB
Low Energy Direct Current Thermal Ablation System
Premarket Submissions
Submission Number:
K212871
Supplement Number:
000