Osseous

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS FDA UDI
Generic Name: Nasal mucosa dressing, non-antimicrobial FDA UDI
Device Name: Standard Nasal Dressings sponges are designed to be placed inside the nasal cavities for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and allowing smooth septum ventilation to ensure patient comfort. The device in invasive with respect to body orifice. FDA UDI
Model / Reference: E7178-OC FDA UDI
Description: Standard Nasal Dressings sponges are designed to be placed inside the nasal cavities for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and allowing smooth septum ventilation to ensure patient comfort. The device in invasive with respect to body orifice. FDA UDI

Identifiers

Primary DI / UDI-DI: 08904428722259 FDA UDI
FDA Product Code: EMX FDA UDI
GMDN Term: Nasal mucosa dressing, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4100 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

Yes

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: Length — 4.5 Centimeter FDA UDI
Height — 1.5 Centimeter FDA UDI
Width — 2.0 Centimeter FDA UDI

Category: Nasal mucosa dressing, non-antimicrobial

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

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Also classified as Nasal mucosa dressing, non-antimicrobial.

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NeilMed Nasogel — NeilMed Pharmaceuticals Inc. · Class I
OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I
OSSEOUS — EON MEDITECH PRIVATE LIMITED · Class I

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 ab9261be-d5b2-4b32-bbfe-e3618b004983 35 fields · synced May 31, 2026