DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756028981
• Version / Model: 31-703
• Catalog Number: 31-703
• 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: 5cafa64a-8918-4de6-aa16-f93733c1dab5

Device Description

PETROLEUM JELLY

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
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
33587	General-body orifice lubricant, non-sterile	A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756028986	GS1	Case	50	In Commercial Distribution
Primary	00749756028981	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973507	000