Depthalon

FDA UDI

Class II (US FDA UDI)

by Pmt Corp.

Identity

Trade Name: DEPTHALON FDA UDI
Generic Name: Depth electrode FDA UDI
Device Name: PLATINUM, 4 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 12.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH FDA UDI
Model / Reference: 2102-04-131 FDA UDI
Description: PLATINUM, 4 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 12.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH FDA UDI

Identifiers

Primary DI / UDI-DI: 00650551001881 FDA UDI
FDA Product Code: GZL FDA UDI
GMDN Term: Depth electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Depth electrode

Depthalon by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Depth electrode.

NexDrive Electrode Holder — Alpha Omega Engineering Corp. · Class II
microTargeting™ Electrode — FHC, INC. · Class II
Macro Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
Spencer Probe Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
Spencer Probe Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
Foramen Ovale Depth Electrode — Ad-Tech Medical Instrument Corp. · Class II
OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
NeuroSmart MER Headstage — Alpha Omega Engineering Corp. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Pmt Corp.

Sources (1)

FDA UDI 700d6985-d1d1-4521-b5ab-13285f48a4b1 33 fields · synced Jun 8, 2026