← Back to catalogue

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
Sinus Packs sponges are designed to be placed inside the sinus cavity for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding. FDA UDI
Model / Reference
E7191-C FDA UDI
Description
Sinus Packs sponges are designed to be placed inside the sinus cavity for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding. FDA UDI

Identifiers

Primary DI / UDI-DI
08904428721771 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

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
Length — 3.5 Centimeter FDA UDI
Height — 1.2 Centimeter FDA UDI
Width — 0.6 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

Similar devices

Also classified as Nasal mucosa dressing, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Eon Meditech Private Limited

Sources (1)

  • FDA UDI b6cdb899-cef2-4caf-ad22-59d86e1c598e 35 fields · synced May 30, 2026