Anodyne Surgical

FDA UDI

Class II (US FDA UDI)

by Psi/Eye-Ko, Inc.

Identity

Trade Name: Anodyne Surgical FDA UDI
Generic Name: Ophthalmic sponge FDA UDI
Device Name: PVA Spear FDA UDI
Model / Reference: FA01-0101-0580 FDA UDI
Description: PVA Spear FDA UDI

Identifiers

Primary DI / UDI-DI: 00840516113753 FDA UDI
510(k) Number: K082460 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic sponge

Anodyne Surgical by Psi/Eye-Ko, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic sponge.

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NETCELL — Network Medical Products, Ltd. · Class II
Eyetec — Network Medical Products, Ltd. · Class II
Visitec® — Beaver-Visitec International, Inc. · Class II
Coronet — Network Medical Products, Ltd. · Class II
Kitpack — Network Medical Products, Ltd. · Class II
Ultracell — Beaver-Visitec International, Inc. · Class II

Cleared under the same submission

K082460 also covers:

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: Psi/Eye-Ko, Inc.

Sources (1)

FDA UDI 9a935630-59c1-4adc-b141-b481cf033875 36 fields · synced Jun 8, 2026