Aliya Needle

GUDID 10850031859002

Aliya Needle, 5 pack

Galvanize Therapeutics, Inc.

Irreversible electroporation system percutaneous probe

• Primary Device ID: 10850031859002
• NIH Device Record Key: 5256ff86-9356-4407-b29c-78bd738efbc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aliya Needle
• Version Model Number: GTI-00023
• Company DUNS: 070000990
• Company Name: Galvanize Therapeutics, Inc.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00850031859005 [Unit of Use]
GS1	10850031859002 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-29
• Device Publish Date: 2024-02-21

Devices Manufactured by Galvanize Therapeutics, Inc.

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