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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 surgical drape FDA UDI
Device Name
Ophthalmic Drape, Full Incise, No Pouch 48 x 51 Embossed Plastic FDA UDI
Model / Reference
10852171007428 FDA UDI
Description
Ophthalmic Drape, Full Incise, No Pouch 48 x 51 Embossed Plastic FDA UDI

Identifiers

Catalog Number
OPD1060NS FDA UDI
Primary DI / UDI-DI
10852171007428 FDA UDI
510(k) Number
K854613 FDA UDI
FDA Product Code
HMT FDA UDI
GMDN Term
Ophthalmic surgical drape FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 51 Inch FDA UDI
Width — 48 Inch FDA UDI

Category: Ophthalmic surgical drape

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 surgical drape.

Cleared under the same submission

K854613 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atlanta Healthcare Services

Sources (1)

  • FDA UDI ac11cfba-738f-4adb-90b9-aba18da01edb 37 fields · synced May 30, 2026