DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756390163
• Version / Model: SY-0831
• Catalog Number: SY-0831
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-10
• Public Version: 1
• Public Version Date: 2023-03-20
• Public Version Status: New
• Public Device Record Key: 6f3cb56a-d693-48c3-8508-142e7c3bc995

Device Description

Control Syringe 8cc Male Rotator

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXT	Injector and syringe, angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15286	Angiographic syringe	A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756390168	GS1	CA	100	In Commercial Distribution
Primary	00749756390163	GS1