Model: H787204003010
Catalog: 20400301
DI: 15051684017954
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Single Electrode Probe Spacer
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2d600d47-daa5-43a3-ad0a-7d4de283193f
Distribution Status:
In Commercial Distribution
DUNS Number:
079252781
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
BX
Item #1 - Device ID:
25051684017951
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
15051684017954
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
15051684017954
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
H787204003010
Item #3 - Device ID Type:
Previous
Item #3 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 58836
Name: Irreversible electroporation system
Definition:
A mobile assembly of devices designed to apply a series of microsecond electrical pulses to tissue to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. The system typically consists of both a mains electricity (AC-powered) computerized current generator with user interface and controls (e.g., foot-switch), and additional necessary components such as electrocardiogram (ECG) trigger monitor and sterile needle-like electrode probes. It is intended for the nonthermal surgical ablation of soft-tissues (e.g., tumours, endothelium).
FDA Product Codes
OAB
Low energy direct current thermal ablation system
Premarket Submissions
Item #1 - Submission Number:
K150089
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K183385
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K242687
Item #3 - Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
27
Storage Handling - Storage Handling Type:
Storage Environment Temperature