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: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide FDA UDI
Model / Reference: 10852171007183 FDA UDI
Description: Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide FDA UDI

Identifiers

Catalog Number: DRA7352 FDA UDI
Primary DI / UDI-DI: 10852171007183 FDA UDI
FDA Product Code: KKX FDA UDI
PUI FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 42 Inch FDA UDI
Width — 24 Inch FDA UDI

Category: Medical equipment/instrument drape, single-use

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 Medical equipment/instrument drape, single-use.

Plasdent — PLASDENT CORP. · Class II
Exact Medical Manufacturing, Inc. — Exact Medical Manufacturing · Class II
Proteger — DAS Medical International SRL · Class II
Machine Bag — Dynarex Corp. · Class I
TIDIShield — TIDI PRODUCTS, LLC · Class II
MICROTEK — Microtek Medical LLC · Class II
Plasdent — PLASDENT CORP. · Class II
Probe Cover — Advance Medical Designs, Inc. · Class II

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 609cfe54-906e-45a0-b6b3-7bf89bb09544 36 fields · synced Jun 8, 2026