AccessGUDID - DEVICE: Aliya Generator-Recertified (00850031859104)

GUDID

Device Identifier (DI) Information

Brand Name: Aliya Generator-Recertified
Version or Model: GTI-00017R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Galvanize Therapeutics, Inc.

Primary DI Number: 00850031859104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070000990 *Terms of Use

Device Description: Aliya Generator - recertified

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64224	Irreversible electroporation system generator	A mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. It includes controls (e.g., foot-switch) and user interface; additional system components necessary for the procedure [e.g., electrocardiogram (ECG) trigger monitor electrode probe/catheter] are not included. It is intended for the nonthermal surgical ablation of soft-tissues and may be intended for one or more clinical application(s).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAB	Low Energy Direct Current Thermal Ablation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212871	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79e74538-ee64-4cbc-8aea-7ca318b8e1d9
Public Version Date: March 10, 2025
Public Version Number: 1
DI Record Publish Date: February 28, 2025