PVA Foam Surgical Spear

FDA UDI

Class II (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: PVA Foam Surgical Spear FDA UDI
Generic Name: Ophthalmic sponge FDA UDI
Device Name: PVA Foam Surgical Spear FDA UDI
Model / Reference: B-0525 FDA UDI
Description: PVA Foam Surgical Spear FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819005866 FDA UDI
FDA Product Code: HOZ FDA UDI
GMDN Term: Ophthalmic sponge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4790 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic sponge

A comprehensive surgical device made of PVA foam, designed for microsurgical procedures and ophthalmic surgery.

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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 II	Pending data

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Manufacturer

Manufacturer: OASIS Medical, Inc.

Sources (1)

FDA UDI 48778653-faf1-4d3e-9f60-880903d05f0f 34 fields · synced Jul 9, 2026