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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
Laryngectomy tube FDA UDI
Device Name
Laryngectomy Tube is designed to maintain an airway of Laryngectomy and also to maintain the opening of the tracheostoma. FDA UDI
Model / Reference
E31108LF FDA UDI
Description
Laryngectomy Tube is designed to maintain an airway of Laryngectomy and also to maintain the opening of the tracheostoma. FDA UDI

Identifiers

Primary DI / UDI-DI
08904428753024 FDA UDI
FDA Product Code
KAC FDA UDI
GMDN Term
Laryngectomy tube 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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 — 55.01 Millimeter FDA UDI
Outer Diameter — 31.55 Millimeter FDA UDI
Lumen/Inner Diameter — 25.91 Millimeter FDA UDI

Category: Laryngectomy tube

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

Similar devices

Also classified as Laryngectomy tube.

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 9235f0cd-a69a-4863-a1fa-a2589e74e294 35 fields · synced May 29, 2026