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ABR OAE Probe Interface PCB service kit

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name
ABR OAE Probe Interface PCB service kit FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
OAE Probe Interface PCB service kit for ABR Module Otoport/Otocheck FDA UDI
Model / Reference
ABR-INT-KIT FDA UDI
Description
OAE Probe Interface PCB service kit for ABR Module Otoport/Otocheck FDA UDI

Identifiers

Primary DI / UDI-DI
05060396172922 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered

ABR OAE Probe Interface PCB service kit by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Otoacoustic emission system, battery-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Otodynamics

Sources (1)

  • FDA UDI 571a846d-a46a-45c5-b088-40b2b50f49ac 33 fields · synced Jun 6, 2026