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Interacoustics

FDA UDI

Class I (US FDA UDI)

by Interacoustics A/S

Identity

Trade Name
Interacoustics FDA UDI
Generic Name
Vestibulo-auditory analysis system support kit¿ FDA UDI
Device Name
Audiometric ear tip kit FDA UDI
Model / Reference
Pediatric Eartip Kit FDA UDI
Description
Audiometric ear tip kit FDA UDI

Identifiers

Primary DI / UDI-DI
05711117122053 FDA UDI
FDA Product Code
ETT FDA UDI
GMDN Term
Vestibulo-auditory analysis system support kit¿ FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vestibulo-auditory analysis system support kit¿

Interacoustics by Interacoustics A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vestibulo-auditory analysis system support kit¿.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Interacoustics A/S

Sources (1)

  • FDA UDI 8d797cf1-acf5-4e7e-b31c-e73f0c31ff13 33 fields · synced May 29, 2026