DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756557269
• Version / Model: 94-0268
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 5d9afce2-9fd1-4aba-b770-29c3651474f8

Device Description

LAPAROSCOPIC TRAY PGYBK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32031	Indwelling urethral catheterization kit, adult	A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756557264	GS1	Case	2	In Commercial Distribution
Primary	00749756557269	GS1

Customer Contacts

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