DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756397759
• Version / Model: 9398-02
• Catalog Number: 9398-02
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-13
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: 9bf04571-6232-4477-a03d-683ffbf1ccc7

Device Description

7 x 10 in Cold Gel Packs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IME	Pack, hot or cold, reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37240	Musculoskeletal hot/cold therapy pack, reusable	A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756397759	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]