DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756036948
• Version / Model: 17-10013
• Catalog Number: 17-10013
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-29
• Public Version: 1
• Public Version Date: 2021-07-07
• Public Version Status: New
• Public Device Record Key: b2037091-5d20-4457-a2d0-b60aad96c4a7

Device Description

Shoulder Suspension

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
IQQ	JOINT, SHOULDER, EXTERNAL LIMB COMPONENT	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756036943	GS1	Case	100	In Commercial Distribution
Primary	00749756036948	GS1

Customer Contacts

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