DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756810401
• Version / Model: D4523
• Catalog Number: D4523
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-09
• Public Version: 1
• Public Version Date: 2021-07-19
• Public Version Status: New
• Public Device Record Key: 6a7bc9e3-0637-4f9f-8c96-96248074cd96

Device Description

Safety Scalpel

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
GDZ	HANDLE, SCALPEL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756810406	GS1	Case	50	In Commercial Distribution
Primary	00749756810401	GS1
Package	30749756810402	GS1	Box	25	In Commercial Distribution

Customer Contacts

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