OSSEOUS Myringotomy knife

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS Myringotomy knife FDA UDI
Generic Name: Nasal knife FDA UDI
Device Name: Myringotomy Knife is used to make an incision in the tympanic membrane (ear drum) into which a “Grommet” can be placed. The handle design aids orientation for accuracy and confidence when making incisions. The consistently sharp, angled blade facilitates a clean cut. FDA UDI
Model / Reference: EI0966 FDA UDI
Description: Myringotomy Knife is used to make an incision in the tympanic membrane (ear drum) into which a “Grommet” can be placed. The handle design aids orientation for accuracy and confidence when making incisions. The consistently sharp, angled blade facilitates a clean cut. FDA UDI

Identifiers

Primary DI / UDI-DI: 08906039319668 FDA UDI
FDA Product Code: JYG FDA UDI
GMDN Term: Nasal knife 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 — 5.38 Millimeter FDA UDI
Length — 172 Millimeter FDA UDI

Category: Nasal knife

OSSEOUS Myringotomy knife 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 d3c74f86-54ec-47cc-a062-c6a4dccf38be 35 fields · synced May 31, 2026