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Osseous

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name
OSSEOUS FDA UDI
Generic Name
Ear wick, non-biodegradable FDA UDI
Device Name
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external. FDA UDI
Model / Reference
E7167-OC FDA UDI
Description
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external. FDA UDI

Identifiers

Primary DI / UDI-DI
08904428721580 FDA UDI
FDA Product Code
KCN FDA UDI
GMDN Term
Ear wick, non-biodegradable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 12 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Ear wick, non-biodegradable

Osseous by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear wick, non-biodegradable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eon Meditech Private Limited

Sources (1)

  • FDA UDI bf9f2dff-acdb-474d-b468-a9ff1349692c 35 fields · synced Jun 8, 2026