Osseous

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS FDA UDI
Generic Name: Tracheostoma button FDA UDI
Device Name: Laryngectomy Button is a self-retaining holder for device in the intended for vocal and pulmonary rehabilitation after Laryngectomy. It can supply stomal support and help to keep the tracheostoma open. FDA UDI
Model / Reference: E3131030 FDA UDI
Description: Laryngectomy Button is a self-retaining holder for device in the intended for vocal and pulmonary rehabilitation after Laryngectomy. It can supply stomal support and help to keep the tracheostoma open. FDA UDI

Identifiers

Primary DI / UDI-DI: 08904428723751 FDA UDI
FDA Product Code: KAC FDA UDI
GMDN Term: Tracheostoma button FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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: Length — 30 Millimeter FDA UDI
Outer Diameter — 15 Millimeter FDA UDI

Category: Tracheostoma button

Osseous 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 b1dcc4b9-0dc4-4007-b86c-191ffd8c997a 35 fields · synced Jun 1, 2026