Atlanta Healthcare Services OcuDrape®

FDA UDI

Class II (US FDA UDI)

by Atlanta Healthcare Services

Identity

Trade Name: Atlanta Healthcare Services OcuDrape® FDA UDI
Generic Name: Ophthalmic sponge FDA UDI
Device Name: PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm STERILE FDA UDI
Model / Reference: 10852171007718 FDA UDI
Description: PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm STERILE FDA UDI

Identifiers

Catalog Number: 3000 FDA UDI
Primary DI / UDI-DI: 10852171007718 FDA UDI
510(k) Number: K942642 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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 3.15 Inch FDA UDI
Length — 3 Inch FDA UDI

Category: Ophthalmic sponge

Atlanta Healthcare Services OcuDrape® by Atlanta Healthcare Services — 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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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

K942642 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: Atlanta Healthcare Services

Sources (1)

FDA UDI bb5690a9-31d9-4f25-a22c-fb5b910fd153 37 fields · synced Jun 1, 2026