AccessGUDID - DEVICE: Aliya Electrode (10850031859026)

GUDID

Device Identifier (DI) Information

Brand Name: Aliya Electrode
Version or Model: GTI-00024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Galvanize Therapeutics, Inc.

Primary DI Number: 10850031859026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 070000990 *Terms of Use

Device Description: Aliya Electrode, 5 pack

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:	Yes
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?
67086	Irreversible electroporation system probe connection electrode	A slender electrical conductor with a connection cable intended to be inserted within the lumen of an irreversible electroporation system probe (i.e., a percutaneous and/or endoscopic probe) to deliver short electrical pulses, in a monopolar configuration, from a system generator to the probe to produce irreversible cell membrane electroporation, for ablation of soft tissue (excludes cardiac tissue). The device does not have direct contact with tissues (i.e., it is not a probe). This is a single-use device.	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: Yes
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: 472a4db7-c3bf-428e-8175-ef9f71e0e67e
Public Version Date: February 21, 2025
Public Version Number: 2
DI Record Publish Date: February 21, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00850031859029 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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