Leukoplast®

FDA UDI

Class I (US FDA UDI)

by Bsn Medical, Inc.

Identity

Trade Name: Leukoplast® FDA UDI
Generic Name: Eye patch FDA UDI
Device Name: LEUKOPLAST EYE OCCLUSOR 4.7CM X 6.7CM JUNIOR TAN 30 HOSP FDA UDI
Model / Reference: 76467-00 FDA UDI
Description: LEUKOPLAST EYE OCCLUSOR 4.7CM X 6.7CM JUNIOR TAN 30 HOSP FDA UDI

Identifiers

Catalog Number: 76467-00 FDA UDI
Primary DI / UDI-DI: 04042809687491 FDA UDI
FDA Product Code: HMP FDA UDI
GMDN Term: Eye patch FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4440 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

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 4.7 Centimeter FDA UDI
Length — 6.7 Centimeter FDA UDI

Category: Eye patch

Leukoplast® by Bsn Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye patch.

COVERCLUDE OCCLUSION EYE PATCHES — FRESNEL PRISM & LENS CO. · Class I
VISION SCREENING PATCH — FRESNEL PRISM & LENS CO. · Class I
Sharn Inc — Sharn Anesthesia · Class I
MYI OCCLUSION EYE PATCHES — FRESNEL PRISM & LENS CO. · Class I
Optego — Optego Vision USA, Inc. · Class I
Sharn Inc — Sharn Anesthesia · Class I
iPRO — FANNIN (UK) LIMITED · Class I
Optego — Optego Vision USA, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Bsn Medical, Inc.

Sources (1)

FDA UDI 97e417ee-1262-4f99-9041-45a15f8b08dd 36 fields · synced May 29, 2026