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: DEPTH ELECTRODE, PLATINUM, 5 CONTACT, INLINE CONNECTOR FDA UDI
Model / Reference: 2102-05-048-NS FDA UDI
Description: DEPTH ELECTRODE, PLATINUM, 5 CONTACT, INLINE CONNECTOR FDA UDI

Identifiers

Catalog Number: 2102-05-048-NS FDA UDI
Primary DI / UDI-DI: 00650551068815 FDA UDI
510(k) Number: K151790 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Hydrogen Peroxide FDA UDI

Category: Depth electrode

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

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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

Cleared under the same submission

K151790 also covers:

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

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Manufacturer

Manufacturer: Pmt Corp.

Sources (1)

FDA UDI 84ab2b16-2854-42be-99a4-49db38f473e8 38 fields · synced Jun 8, 2026