DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: General-purpose surgical sponge FDA UDI
Device Name: Tonsil Sponge Pack FDA UDI
Model / Reference: 32-683 FDA UDI
Description: Tonsil Sponge Pack FDA UDI

Identifiers

Catalog Number: 32-683 FDA UDI
Primary DI / UDI-DI: 00749756033527 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: General-purpose surgical sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General-purpose surgical sponge

DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical sponge.

Centurion — Centurion Medical Products · Class I
Dermapac, Inc. — Dermapac Inc. · Class I
A Plus — A PLUS INTERNATIONAL, INC · U
A Plus — A PLUS INTERNATIONAL, INC · U
Centurion — Centurion Medical Products · Class I
AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY · Class I
Dermacea — Cardinal Health 200, LLC · Class I
Dermapac, Inc. — Dermapac 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Deroyal Industries, Inc.

Sources (1)

FDA UDI 74f0b449-5bbf-4b33-86da-c19c1fe01195 35 fields · synced Jun 8, 2026