DPOAE probe tips

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name: DPOAE probe tips FDA UDI
Generic Name: Otoacoustic emission system, line-powered FDA UDI
Model / Reference: T-R4.8S FDA UDI

Identifiers

Primary DI / UDI-DI: 05060396170935 FDA UDI
FDA Product Code: GWJ FDA UDI
EWO FDA UDI
GMDN Term: Otoacoustic emission system, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 FDA UDI
874.1050 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

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

MRI Safety

MR Unsafe FDA UDI

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

DPOAE probe tips 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 bb7acf57-4116-4163-87f2-4aebb70166c3 32 fields · synced May 30, 2026