Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 10194717107668
• Version / Model: LD00358L
• Company Name: ROI CPS, LLC
• Labeler DUNS: 117174678
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-23
• Public Version: 2
• Public Version Date: 2021-01-21
• Public Version Status: Update
• Public Device Record Key: 1ee8f49a-9610-4c91-8133-81fb8a225a6a
• Distribution End Date: 2021-01-20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHM	Cesarean Section Tray	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194717107665	GS1		2	Not in Commercial Distribution	2021-01-20
Primary	10194717107668	GS1