DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756024792
• Version / Model: 30-328
• Catalog Number: 30-328
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-30
• Public Version: 1
• Public Version Date: 2021-07-08
• Public Version Status: New
• Public Device Record Key: dd5d1705-1fd5-4e4f-b35e-ff5eaabf27dc

Device Description

UNDERCAST PADDING

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITG	BANDAGE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59049	General-purpose medical fibre padding	A roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756024797	GS1	Case	20	In Commercial Distribution
Primary	00749756024792	GS1

Customer Contacts

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