ABR Case service kit - Top

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name: ABR Case service kit - Top FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Case service kit (Top section enclosure) for ABR Module Otoport/Otocheck FDA UDI
Model / Reference: ABR-CTOP-KIT FDA UDI
Description: Case service kit (Top section enclosure) for ABR Module Otoport/Otocheck FDA UDI

Identifiers

Primary DI / UDI-DI: 05060396172717 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

Yes

FDA UDI

Serial Number

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

ABR Case service kit - Top 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 5a082643-4544-42fe-bdeb-cb17c1b636e5 33 fields · synced Jun 8, 2026