Tip Sample Box (Neonate)

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name: Tip Sample Box (Neonate) FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Compartmented box including a sample of assorted probe tips and tip holders. For use with X-series probes. FDA UDI
Model / Reference: NEO-BOX FDA UDI
Description: Compartmented box including a sample of assorted probe tips and tip holders. For use with X-series probes. FDA UDI

Identifiers

Primary DI / UDI-DI: 05060396172595 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

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

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

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

Tip Sample Box (Neonate) by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Otoacoustic emission system, battery-powered.

ECochG Adapters — Vivosonic Inc · Class II
Integrity OAE Probe — Vivosonic Inc · Class II
Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
Interacoustics — Interacoustics A/S · Class II
Lucid Hearing ® — ETYMOTIC RESEARCH, INC. · Class II
Maico — MAICO Diagnostics GmbH · Class II
Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Otodynamics

Sources (1)

FDA UDI 0a5e7530-07cb-433b-9eac-9e3c9aa904d6 33 fields · synced Jun 6, 2026