DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756023801
• Version / Model: 30-409
• Catalog Number: 30-409
• 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: 8a776c47-e2a7-429b-bc3b-aa0307f4df9f

Device Description

UMBILICAL TAPE

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: 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
FOD	DEVICE, OCCLUSION, UMBILICAL	General Hospital	880.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13983	Umbilical cord tape	A thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756023806	GS1	Case	100	In Commercial Distribution
Primary	00749756023801	GS1

Customer Contacts

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