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Otoport Keypad PCB Assembly

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name
Otoport Keypad PCB Assembly FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Keypad PCB Assembly service part for Otoport/Otocheck FDA UDI
Model / Reference
OP-KEY-KIT FDA UDI
Description
Keypad PCB Assembly service part for Otoport/Otocheck FDA UDI

Identifiers

Primary DI / UDI-DI
05060396172908 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

Otoport Keypad PCB Assembly 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 324520e5-aea4-4784-9107-a39631f6eacb 33 fields · synced May 30, 2026