DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: Hand/finger splint, single-use FDA UDI
Device Name: Wire Foam™ Resting Splint FDA UDI
Model / Reference: 125DL FDA UDI
Description: Wire Foam™ Resting Splint FDA UDI

Identifiers

Catalog Number: 125DL FDA UDI
Primary DI / UDI-DI: 00749756125192 FDA UDI
FDA Product Code: ILH FDA UDI
GMDN Term: Hand/finger splint, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hand/finger splint, single-use

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

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Also classified as Hand/finger splint, single-use.

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DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, 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: Deroyal Industries, Inc.

Sources (1)

FDA UDI 133bfb82-7f90-42dd-8318-13a896727bc3 35 fields · synced Jun 8, 2026