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: Remote Control Cover, Clear Plastic w/ tape and flap FDA UDI
Model / Reference: 10852171007190 FDA UDI
Description: Remote Control Cover, Clear Plastic w/ tape and flap FDA UDI

Identifiers

Catalog Number: OPH504NS FDA UDI
Primary DI / UDI-DI: 10852171007190 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

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: Width — 5 Inch FDA UDI
Length — 9 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

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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 8baa837d-5cc6-4611-950d-fcbc5c31f893 36 fields · synced May 30, 2026