DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756024457
• Version / Model: 59-0803NS
• Catalog Number: 59-0803NS
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: e46f03bf-bd1d-4c67-aa38-e70213eb44af

Device Description

Satchel Sheet

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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30035	Floor covering	A material intended to be used to cover the floor of a room where certain consideration must be taken to the degree of safety and/or hygiene required. It is typically used as a non-slip surface, a water-resistant surface, and/or an industrial surface in areas such as examination rooms or operating rooms; it may be conductive, to reduce the risk of static electricity, or non-conductive.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756024452	GS1	Case	10	In Commercial Distribution
Primary	00749756024457	GS1

Customer Contacts

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