DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756838528
• Version / Model: HD-395-2500EU
• Catalog Number: HD-395-2500EU
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-23
• Public Version: 1
• Public Version Date: 2021-07-01
• Public Version Status: New
• Public Device Record Key: 83d187f6-95d3-4afd-93a2-b4b2bc7d0442

Device Description

SPONGE BOWL - BLUE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
FNY	BASIN, EMESIS	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46929	Sponge bowl, single-use	A sterile receptacle specifically designed to store and/or collect sponges. It is typically made of plastic or metallic [e.g., aluminium (Al)] foil, is frequently changed, and has single-patient application; it may be prepacked containing the sponges. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756838523	GS1	Case	160	In Commercial Distribution
Primary	00749756838528	GS1

Customer Contacts

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