DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756798433
• Version / Model: 404W61
• Catalog Number: 404W61
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-23
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f65768e6-86a7-425d-87ed-cf6ff3605098

Device Description

BASEBALL FINGER SPLINT

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILH	SPLINT, HAND, AND COMPONENTS	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16210	Hand/finger splint, single-use	A prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756798438	GS1	Case	12	In Commercial Distribution
Primary	00749756798433	GS1

Customer Contacts

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