INUMI Flex Needle

GUDID 00850031859074

INUMI Flex Needle, 5 pack

Galvanize Therapeutics, Inc.

Irreversible electroporation system endoscopic probe

• Primary Device ID: 00850031859074
• NIH Device Record Key: 46ea18ed-4bfc-430b-9341-1247f1ac82cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INUMI Flex Needle
• Version Model Number: GTI-00054
• 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	00850031859074 [Unit of Use]
GS1	00850031859081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233884

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by Galvanize Therapeutics, Inc.

• 00850031859074 - INUMI Flex Needle: 2025-03-10INUMI Flex Needle, 5 pack
• 00850031859074 - INUMI Flex Needle: 2025-03-10 INUMI Flex Needle, 5 pack
• 00850031859104 - Aliya Generator-Recertified: 2025-03-10 Aliya Generator - recertified
• 00850031859043 - Aliya Generator: 2025-03-03 Aliya Generator, 2.5
• 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