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 Ophthalmic Wipe 3IN1 Wipe, Drain Wick, Corneal Light Shield 80mm x 76mm x 2mm STERILE FDA UDI
Model / Reference: 10852171007794 FDA UDI
Description: PVA Ophthalmic Wipe 3IN1 Wipe, Drain Wick, Corneal Light Shield 80mm x 76mm x 2mm STERILE FDA UDI

Identifiers

Catalog Number: 3210 FDA UDI
Primary DI / UDI-DI: 10852171007794 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: Length — 3 Inch FDA UDI
Width — 3.15 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

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

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

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

Manufacturer

Manufacturer: Atlanta Healthcare Services

Sources (1)

FDA UDI 63823b77-74ff-45ad-8d70-e113fc5597e3 37 fields · synced Jun 1, 2026