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 Instrument Wipe FDA UDI
Model / Reference: FA01-1501-0120 FDA UDI
Description: PVA Instrument Wipe FDA UDI

Identifiers

Primary DI / UDI-DI: 00840516113791 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

Similar devices

Also classified as Ophthalmic sponge.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Psi/Eye-Ko, Inc.

Sources (1)

FDA UDI 7d62dc5e-6432-40d3-bcad-7e594cd706f3 36 fields · synced May 30, 2026