Single Use Eartip

FDA UDI

Class II (US FDA UDI)

by Etymotic Research, Inc.

Identity

Trade Name: Single Use Eartip FDA UDI
Generic Name: Audiometric ear tip FDA UDI
Device Name: 6mm Single Use Ear tip 100pk FDA UDI
Model / Reference: ER10-T06 FDA UDI
Description: 6mm Single Use Ear tip 100pk FDA UDI

Identifiers

Primary DI / UDI-DI: 00846430004108 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

Yes

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 — 6 Millimeter FDA UDI

Category: Audiometric ear tip

Single Use Eartip by Etymotic Research, Inc. — 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: Etymotic Research, Inc.

Sources (1)

FDA UDI a778fdbe-6cb3-4686-8f12-5497c47e1608 34 fields · synced Jun 6, 2026