Aliya Electrode

Basic Information

• Brand Name: Aliya Electrode
• Primary DI: 10850031859026
• Version / Model: GTI-00024
• Company Name: Galvanize Therapeutics, Inc.
• Labeler DUNS: 070000990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-02-21
• Public Version: 1
• Public Version Date: 2024-02-29
• Public Version Status: New
• Public Device Record Key: 472a4db7-c3bf-428e-8175-ef9f71e0e67e

Device Description

Aliya Electrode, 5 pack

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
67086	Irreversible electroporation system percutaneous probe connection electrode	A slender electrical conductor with a connection cable intended to be inserted within the lumen of an irreversible electroporation system percutaneous probe to deliver short electrical pulses, in a monopolar configuration, from a system generator to the probe to produce irreversible cell membrane electroporation. The thin distal electrode is intended to be inserted within the probe lumen for during ablation of soft tissue (excludes cardiac tissue); it does not have direct contact with tissues (i.e., not a probe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850031859026	GS1
Unit of Use	00850031859029	GS1

Premarket Submissions

Submission Number	Supplement Number
K212871	000