DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756048255
• Version / Model: 9844-43
• Catalog Number: 9844-43
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-03-08
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 41adbe42-5fc3-43c2-8128-aab8d13f989d

Device Description

Bias Stockinette 4In X 3YD4/Pk 25Pk/Cs

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
IPM	COVER, LIMB	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35374	Stockinette	A knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756048250	GS1	CA	25	In Commercial Distribution
Primary	00749756048255	GS1
Unit of Use	10749756048252	GS1