DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756791373
• Version / Model: TM500DE
• Catalog Number: TM500DE
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-28
• Public Version: 1
• Public Version Date: 2021-08-05
• Public Version Status: New
• Public Device Record Key: 628d028b-5027-4d7d-bf77-3b0d1aaa6868

Device Description

Laparoscopic Scope Warmer

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: Yes
• 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
NWV	Laparoscopic accessories, gynecologic	Obstetrics/Gynecology	884.1720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63518	Instrument warmer, exothermic chemical	A sterile heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of an envelope that is wrapped around the instrument (e.g., laparoscope), and filled with a material which produces an exothermic chemical reaction when activated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756791378	GS1	Case	10	In Commercial Distribution
Primary	00749756791373	GS1

Customer Contacts

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