DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756037419
• Version / Model: 30-059
• Catalog Number: 30-059
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-30
• Public Version: 1
• Public Version Date: 2021-07-08
• Public Version Status: New
• Public Device Record Key: 926ee7d4-2f86-448e-b296-0f7f4d310bba

Device Description

Neuro Sponges

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: No
• 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
EFQ	GAUZE/SPONGE, INTERNAL	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30749756037410	GS1	Box	20	In Commercial Distribution
Primary	00749756037419	GS1
Package	50749756037414	GS1	Case	20	In Commercial Distribution

Customer Contacts

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