DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: Surgical plume evacuation system FDA UDI
Device Name: Electrosurgical Pencil and Holster FDA UDI
Model / Reference: 88-000602 FDA UDI
Description: Electrosurgical Pencil and Holster FDA UDI

Identifiers

Primary DI / UDI-DI: 00749756157865 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Surgical plume evacuation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical plume evacuation system

DeRoyal by Deroyal Industries, Inc. — 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: Deroyal Industries, Inc.

Sources (1)

FDA UDI 740a15ac-84af-43ff-8905-d4e46a5e52ec 34 fields · synced Jun 8, 2026