ArcRoyal

Basic Information

• Brand Name: ArcRoyal
• Primary DI: 16931918133515
• Version / Model: AR-63001NS
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Labeler DUNS: 679894738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: 403d5af0-c19f-496a-92b4-7d4bbd1fb0d3

Device Description

Cotton Towel Blue 17" x 24"(43cmx61cm)_100ea/cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26931918133512	GS1		100	In Commercial Distribution
Primary	16931918133515	GS1

Customer Contacts

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