Dukal

FDA UDI

Class I (US FDA UDI)

by Dukal LLC

Identity

Trade Name: Dukal FDA UDI
Generic Name: Isolation gown, single-use FDA UDI
Device Name: Level 2 Isolation Gown, Universal, Yellow FDA UDI
Model / Reference: 309 FDA UDI
Description: Level 2 Isolation Gown, Universal, Yellow FDA UDI

Identifiers

Catalog Number: 309 FDA UDI
Primary DI / UDI-DI: 10665973028016 FDA UDI
FDA Product Code: OEA FDA UDI
GMDN Term: Isolation gown, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Isolation gown, single-use

Dukal by Dukal LLC — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Dukal LLC

Sources (1)

FDA UDI 9073a2bb-fb28-4345-8945-923abb87112e 35 fields · synced May 31, 2026