DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756249720
• Version / Model: 3540
• Catalog Number: 3540
• 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: 2e4d436f-aea9-420f-8adc-2a7f23fc8a61

Device Description

Umbilical Cord Clamp Clipper

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZT	CUTTER, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47402	Umbilical cord clamp/cutter	A sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756249725	GS1	Case	6	In Commercial Distribution
Primary	00749756249720	GS1

Customer Contacts

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