DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: FOAM WRAP, SHOULDER FDA UDI
Model / Reference: 9381-00 FDA UDI
Description: FOAM WRAP, SHOULDER FDA UDI

Identifiers

Catalog Number: 9381-00 FDA UDI
Primary DI / UDI-DI: 00749756101615 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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: Hot/cold therapy pack, single-use

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

Sources (1)

FDA UDI 7d4ce2ae-03ad-473d-86f5-0db6b456b3b8 35 fields · synced Jun 8, 2026