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OSSEOUS Myringotomy Kit-Standard

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name
OSSEOUS Myringotomy Kit-Standard FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
EI0972 FDA UDI

Identifiers

Primary DI / UDI-DI
08906039319729 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Combination Product

Yes

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

Category: General surgical procedure kit, non-medicated, single-use

OSSEOUS Myringotomy Kit-Standard by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

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 ed490218-2e6c-47bd-9211-722e59509767 33 fields · synced May 30, 2026