Device
MICROWIRE DEPTHALON ELECTRODE, 4 X 2MM CONTACTS MACRO CONTACTS, 16 X 75UM MICROWIRE CONTACTS, 17MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
Manufacturer
PMT CORPORATION
PMT CORPORATION
Model: 2104-04-16-001
DI: 00650551005544
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
MICROWIRE DEPTHALON ELECTRODE, 4 X 2MM CONTACTS MACRO CONTACTS, 16 X 75UM MICROWIRE CONTACTS, 17MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
087e5913-f02c-4be5-9b7e-a4da8837f179
Distribution Status:
In Commercial Distribution
DUNS Number:
039576871
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
Device ID:
00650551005544
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32556
Name: Depth electrode
Definition:
An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.
FDA Product Codes
GZL
Electrode, Depth