XGD Probe

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name: XGD Probe FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: X-series probe for DPOAE and TEOAE hearing screening/analysis; cable length approx. 1 metre (40"), with 8-pin metal plug. For use with Otoport/Otocheck OAE and OAE+ABR instruments FDA UDI
Model / Reference: PR-XGD FDA UDI
Description: X-series probe for DPOAE and TEOAE hearing screening/analysis; cable length approx. 1 metre (40"), with 8-pin metal plug. For use with Otoport/Otocheck OAE and OAE+ABR instruments FDA UDI

Identifiers

Primary DI / UDI-DI: 05060396172199 FDA UDI
FDA Product Code: EWO FDA UDI
GWJ FDA UDI
GMDN Term: Evoked-potential audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1050 FDA UDI
882.1900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Evoked-potential audiometer Otoacoustic emission system, battery-powered

XGD Probe by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Otodynamics

Sources (1)

FDA UDI 6777a2a0-4c3b-44b0-84c1-927e185f1a8a 33 fields · synced Jun 8, 2026