Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10326053119412
• Version / Model: ORTWLBLSTD4-REG
• Catalog Number: ORTWLBLSTD4-REG
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 1
• Public Version Date: 2023-06-22
• Public Version Status: New
• Public Device Record Key: 685dc41c-d650-4b14-a042-878aa0a3c03e

Device Description

OR TOWEL STANDARD BLUE STRL 4/PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	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	20326053119419	GS1		20	In Commercial Distribution
Primary	10326053119412	GS1
Unit of Use	00326053119415	GS1