Aliya Generator

GUDID 00850031859050

Aliya Generator, 2.5

Galvanize Therapeutics, Inc.

Irreversible electroporation system generator

• Primary Device ID: 00850031859050
• NIH Device Record Key: 3aa163cf-1527-49b1-97d7-9e89013971cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aliya Generator
• Version Model Number: GTI-00017
• Company DUNS: 070000990
• Company Name: Galvanize Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031859050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212871

FDA Product Code

• OAB: Low Energy Direct Current Thermal Ablation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-28
• Device Publish Date: 2023-08-18

Devices Manufactured by Galvanize Therapeutics, Inc.

• 10850031859002 - Aliya Needle: 2024-02-29 Aliya Needle, 5 pack
• 10850031859026 - Aliya Electrode: 2024-02-29 Aliya Electrode, 5 pack
• 00850031859050 - Aliya Generator: 2023-08-28Aliya Generator, 2.5
• 00850031859050 - Aliya Generator: 2023-08-28 Aliya Generator, 2.5