OSSEOUS PVA Eye Spears

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS PVA Eye Spears FDA UDI
Generic Name: Ophthalmic sponge FDA UDI
Device Name: A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral surface or to manipulate tissue during an ophthalmic surgical procedure. A PVA sponge is particularly preferred in the LASIK laser surgery due to a very soft cell structure when wet FDA UDI
Model / Reference: E7140 FDA UDI
Description: A sterile compressed PVA sponge spear is used to absorb excess fluids from the corneal / scleral surface or to manipulate tissue during an ophthalmic surgical procedure. A PVA sponge is particularly preferred in the LASIK laser surgery due to a very soft cell structure when wet FDA UDI

Identifiers

Primary DI / UDI-DI: 08904428722648 FDA UDI
FDA Product Code: KCN FDA UDI
GMDN Term: Ophthalmic sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.5220 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

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 72.2 Millimeter FDA UDI
Outer Diameter — 3.58 Millimeter FDA UDI

Category: Ophthalmic sponge

OSSEOUS PVA Eye Spears 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 0ca9f5e2-1d6c-4b2a-8f29-a22b8a9aa756 35 fields · synced Jun 8, 2026