Bio-logic

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Bio-logic FDA UDI
Generic Name: Audiometric ear tip FDA UDI
Device Name: OAE Jumbo Tip FDA UDI
Model / Reference: OAE Jumbo Tip FDA UDI
Description: OAE Jumbo Tip FDA UDI

Identifiers

Catalog Number: 203200 FDA UDI
Primary DI / UDI-DI: 00382830052504 FDA UDI
510(k) Number: K031352 FDA UDI
FDA Product Code: EWO FDA UDI
GMDN Term: Audiometric ear tip FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1050 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

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 0.110 Inch FDA UDI
Length — 0.50 Inch FDA UDI

Category: Audiometric ear tip

Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Natus Medical Incorporated

Sources (1)

FDA UDI 90ceb45e-d9ab-4d8e-b533-ad157a9e0c2d 37 fields · synced Jun 8, 2026