Device
INUMI Flex PEF Ablation Pack, 5 Pack and 1 Pack
Manufacturer
Galvanize Therapeutics, Inc.
Galvanize Therapeutics, Inc.
Model: GTI-00078
DI: 00850031859135
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
INUMI Flex PEF Ablation Pack, 5 Pack and 1 Pack
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2722d84e-e538-4e34-86f1-2431de23ce63
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:
00850031859135
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Carton
Item #2 - Device ID:
00850031859166
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00850031859135
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Box
Item #3 - Device ID:
00850031859012
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
5
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00850031859166
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 67470
Name: Irreversible electroporation system endoscopic probe
Definition:
A hollow, long, tubular electrical conductor with a sharply-pointed distal end intended for endoscopic introduction to deliver short electrical pulses, in a monopolar configuration, to produce irreversible cell membrane electroporation for ablation of soft tissue (excludes cardiac tissue). It is intended to be proximally connected to a connection electrode with a connection cable for use in conjunction with an appropriate generator. It may include a stylet intended to facilitate introduction; the connection electrode and connection cable are not included. This is a single-use device.
FDA Product Codes
OAB
Low Energy Direct Current Thermal Ablation System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K233884
Supplement Number:
000