OSSEOUS Ear Specula

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS Ear Specula FDA UDI
Generic Name: Ear speculum, single-use FDA UDI
Device Name: "Ear Specula is a funnel shaped with oblique end which inserted into the auditory canal of the ear, allowing to look at the ear canal and ear drum. " FDA UDI
Model / Reference: EI0954 FDA UDI
Description: "Ear Specula is a funnel shaped with oblique end which inserted into the auditory canal of the ear, allowing to look at the ear canal and ear drum. " FDA UDI

Identifiers

Primary DI / UDI-DI: 08906039319545 FDA UDI
FDA Product Code: EPY FDA UDI
GMDN Term: Ear speculum, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 6 Millimeter FDA UDI
Outer Diameter — 35 Millimeter FDA UDI

Category: Ear speculum, single-use

OSSEOUS Ear Specula by Eon Meditech Private Limited — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Eon Meditech Private Limited

Sources (1)

FDA UDI fadc8874-293d-4874-a8bb-854735fc2671 35 fields · synced Jun 8, 2026